GS1 Cannulated Screw System
by Gold Standard Orthopaedics, LLC
510(k) K123487
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123487 | Date11 Mar 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Gso GS1 Cannulated Screw System
- 510(k) Number
- FDA Product Code
- MNH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The GS1 Cannulated Screw System is a spinal fixation device classified as a pedicle screw under the FDA’s product code MNH. It is designed for internal fixation of the spine, providing stability to the thoracic, lumbar, and sacral regions through cannulated screws that engage vertebral pedicles. These screws are intended for use in surgical procedures addressing spinal instabilities, deformities, or fractures, including degenerative spondylolisthesis with neurological impairment. The cannulated design allows for precise placement and potential compatibility with other spinal instrumentation systems.
This system is supplied as a sterile, single-use orthopedic implant and is regulated under FDA 510(k) clearance (K123487) as substantially equivalent to a predicate device. It is intended for use in controlled surgical environments, such as operating rooms, by qualified orthopedic surgeons. The cannulated screws are available in specific sizes and configurations to accommodate varying anatomical requirements. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to surgical use.
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Questions
AI-generated answers, 1 Oct 2026
What is the GS1 Cannulated Screw System used for?
The GS1 Cannulated Screw System is designed for internal spinal fixation to stabilize the thoracic, lumbar, and sacral regions. It is intended for surgical procedures addressing spinal instabilities, deformities, or fractures, including degenerative spondylolisthesis with neurological impairment. The cannulated design allows for accurate screw placement and potential compatibility with other spinal instrumentation systems.
Is the GS1 Cannulated Screw System sterile and single-use?
Yes, the GS1 Cannulated Screw System is supplied as a sterile, single-use orthopedic implant. This ensures safety and compliance with medical device protocols, preventing cross-contamination and maintaining sterility before surgical use.
What sizes and configurations are available for the GS1 Cannulated Screw System?
The GS1 Cannulated Screw System is available in specific sizes and configurations tailored to accommodate varying anatomical requirements in spinal fixation procedures. Exact dimensions and options should be referenced in the product documentation or consulted with Gold Standard Orthopaedics for precise selection.
How should the GS1 Cannulated Screw System be stored?
The GS1 Cannulated Screw System must be stored and handled according to sterile medical device protocols to preserve its integrity. This includes maintaining proper packaging, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions.
What regulatory clearance does the GS1 Cannulated Screw System have?
The GS1 Cannulated Screw System holds FDA 510(k) clearance (K123487), confirming it is substantially equivalent to a predicate device under the FDA’s product code MNH for spinal fixation. This clearance ensures it meets regulatory standards for safety and effectiveness in controlled surgical environments.