Codman Titanium Interlaminar Clamp Kit
by Codman & Shurtleff, Inc. 510(k)
Active
510(k) K924142
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924142 | Date15 Jun 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Codman(Tm) Titanium Interlaminar Clamp Kit
- 510(k) Number
- FDA Product Code
- KWP
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Codman Titanium Interlaminar Clamp Kit is a spinal fixation appliance used for interlaminar applications in orthopedic procedures. It is designed to provide stabilization and support in spinal surgeries.
This device is supplied as a kit and is intended for single-use. It is manufactured by Codman & Shurtleff, Inc. and has FDA 510(k) clearance with the product code KWP. The device is available in various sizes as specified by the manufacturer.
Other devices from Codman & Shurtleff, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Codman Titanium Interlaminar Clamp Kit used for?
The Codman Titanium Interlaminar Clamp Kit is a spinal fixation appliance designed for interlaminar applications in orthopedic procedures. It provides stabilization and support during spinal surgeries to help maintain proper spinal alignment and promote healing.
Is the Codman Titanium Interlaminar Clamp Kit reusable or single-use?
The Codman Titanium Interlaminar Clamp Kit is intended for single-use only. It is supplied as a complete kit and should not be reused on multiple patients to ensure patient safety and maintain device integrity.
What sizes are available for the Codman Titanium Interlaminar Clamp Kit?
The Codman Titanium Interlaminar Clamp Kit is available in various sizes as specified by the manufacturer, Codman & Shurtleff, Inc. The specific size options should be selected based on the patient's anatomy and the surgical requirements.
What is the regulatory status of the Codman Titanium Interlaminar Clamp Kit?
The Codman Titanium Interlaminar Clamp Kit has FDA 510(k) clearance with the product code KWP. It was determined to be substantially equivalent to predicate devices through the traditional clearance process, with the Orthopedic advisory committee reviewing the submission.