4CIS VERTU SPINE SYSTEM
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED · Model AISP-2807-6510 · UDI-DI 00840185313232
Description
Mono-axial Cannulated Pedicle Screw, Ø 6.5 mm, 100 mm Length The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-28 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. |
| 2026-05-22 | Innovasis, Inc | Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with unde |
| 2025-09-19 | Orthofix U.S. LLC | Polyaxial screws do not meet performance standards. |
| 2025-06-30 | SPINEART SA | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| 2025-06-30 | SPINEART SA | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| 2024-10-29 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| 2024-10-29 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| 2024-08-21 | XTANT Medical Holdings, Inc | Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and |
| 2024-03-15 | SPINEART SA | Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The |
| 2024-02-28 | SEASPINE ORTHOPEDICS CORPORATION | Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs