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Perlove Medical PL300B Spine Surgical Robotic Navigation & Positioning System with Integrated 3D C-Arm — Complete Turnkey Surgical Suite with Installation, Clinical Training, Toolkits and Consumables

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SKU:
TH-PER-PL300B-3D-TKY
Weight:
5,100.00 LBS
Availability: 21-30 Days ETA.

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Description

The Perlove Medical PL300B Spine Surgical Navigation and Positioning System is a comprehensive image-guided orthopedic surgery platform designed to support precise planning, navigation, instrument positioning and robotic-assisted execution during complex spinal and orthopedic procedures.

The complete system combines an infrared optical tracking platform, intelligent intraoperative planning software, high-resolution visualization, an integrated workstation and a multi-degree-of-freedom robotic positioning arm. When paired with the included 3D C-arm imaging system, the platform creates a unified surgical workflow for image acquisition, anatomical registration, trajectory planning, real-time navigation and robotic guidance.

The PL300B system is designed to support procedures such as percutaneous kyphoplasty, percutaneous pedicle screw fixation, bone biopsy and other image-guided spinal interventions. Its adaptive registration capabilities are intended to align intraoperative imaging data with the patient’s anatomy, while the robotic arm assists with stable, planned positioning of compatible surgical instruments.

Complete Turnkey System Package Includes

  • Perlove Medical PL300B surgical robotic positioning platform
  • Spine surgical navigation and positioning system
  • Infrared optical tracking system
  • Intelligent intraoperative planning software
  • Integrated navigation workstation
  • High-definition medical-grade monitors
  • Multi-degree-of-freedom robotic arm
  • Orthopedic robotic positioning and tracking accessories
  • Integrated 3D C-arm imaging system
  • Surgical navigation software and workflow configuration
  • Surgical instrument and positioning toolkit
  • Orthopedic guides, probes, trackers and positioning instruments
  • Electric drill toolkit and compatible accessories
  • Initial procedural consumables and sterile-use components
  • Tracker adapters, marker components and positioning rings
  • Bone traction pins and compatible procedural accessories
  • Disposable sterile protective covers
  • On-site delivery coordination and system installation
  • System calibration, testing and commissioning
  • Physician, clinical and biomedical engineering training
  • Operator workflow and equipment-use instruction
  • Initial technical support and implementation assistance

The supplied literature identifies the PL300B as a Spine Surgical Navigation and Positioning System and illustrates its tracking, robotic positioning, planning, visualization, surgical toolkit and consumable configurations.

System Total Package Price

$217,700,000.00 USD

Written Amount: Two Hundred Seventeen Million Seven Hundred Thousand United States Dollars.

This price represents the complete bundled system, including the surgical robot, navigation system, integrated 3D C-arm, installation, commissioning, training, surgical toolkits and initial consumables. Final configuration, facility preparation, regulatory documentation, recurring consumables, service coverage, import duties and transportation requirements should be confirmed in the executed purchase agreement.

FDA MedWatch Safety Reporting Notice

The PL300B Spine Surgical Navigation and Robotic Positioning System, including its optical tracking workstation, robotic guidance arm, surgical instruments, consumables, and integrated 3D C-arm, is an emerging complex medical-device platform. Healthcare professionals, facilities, operators, and patients should promptly report any suspected serious injury, death, device malfunction, unintended robotic movement, navigation or registration inaccuracy, tracking loss, imaging failure, software anomaly, electrical or mechanical failure, sterile-barrier breach, or other product-quality concern through the FDA’s MedWatch and Medical Device Reporting channels. Healthcare professionals and consumers may submit voluntary reports using Form FDA 3500 or 3500B; manufacturers, importers, and device user facilities may have mandatory electronic reporting obligations under 21 CFR Part 803.

Regulatory disclaimer: This is a distributor post-market vigilance notice—not an FDA-issued safety alert, recall, clearance, approval, or authorization statement. The supplied product literature describes the PL300B system and its associated equipment but does not establish its U.S. FDA marketing authorization or clearance status. Applicable 510(k), De Novo, PMA, IDE, registration, listing, labeling, and import requirements must be independently verified before commercial distribution or clinical use in the United States.

Warranty

Warranty & Limitations Proposed product-feed language: This turnkey surgical robotics and imaging bundle is supplied with a limited equipment warranty under the terms stated in the final quotation, purchase agreement, and manufacturer documentation. Warranty coverage applies to verified defects in materials or workmanship affecting the surgical robot, navigation workstation, optical tracking components, robotic positioning arm, 3D C-arm, supplied monitors, control hardware, and other covered capital equipment. The seller’s obligation is limited, at its option, to remote troubleshooting, repair, replacement of a defective component, or other corrective service expressly authorized in writing. Installation, calibration, commissioning, and initial operator training are included only to the extent identified in the executed sales agreement. Consumables, sterile covers, marker spheres, traction pins, drill bits, batteries, cables, accessories subject to routine wear, and other single-use or limited-life components are excluded from the capital-equipment warranty unless received defective and reported within the applicable inspection period. Consumables must be stored, handled, and used within their labeled shelf life and instructions. Warranty coverage does not apply to damage resulting from misuse, accident, improper storage, unsuitable electrical supply, inadequate facility conditions, unauthorized installation or repair, modification, cyber or network incidents, failure to perform required maintenance, use of unapproved accessories, improper sterilization, abnormal environmental conditions, transportation after acceptance, or operation outside the manufacturer’s instructions. Facility preparation, radiation shielding, electrical upgrades, networking, permits, licensing, regulatory submissions, customs charges, replacement consumables, travel expenses, and extended service coverage are excluded unless specifically listed. The equipment must be operated only by appropriately trained and credentialed personnel. Product descriptions, images, software displays, and clinical examples are illustrative and do not guarantee procedural success, clinical outcomes, reimbursement, compatibility with every implant or instrument system, or regulatory authorization in every jurisdiction. Availability of particular software modules, accessories, consumables, and third-party components is subject to the final approved configuration. The supplied brochure describes the PL300B system, surgical tools, drill kit, and consumable components but does not state a specific warranty duration; the controlling warranty period should therefore be confirmed in the signed purchase agreement. To the fullest extent permitted by law, implied warranties and liability for indirect, incidental, special, consequential, punitive, or loss-of-use damages are excluded. Any liability relating to a covered claim is limited to the amount paid for the affected product or component.

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