J.B.S. C1-C2 Clamp
by J.B.S., S.A. 510(k)
Active
510(k) K955864
Overview
The J.B.S. C1-C2 Clamp is a spinal fixation device classified under Appliance, Fixation, Spinal Interlaminal, designed for temporary stabilization of the C1-C2 vertebrae. It provides mechanical support to facilitate bony fusion in orthopedic spinal procedures, ensuring proper alignment during the healing process.
This single-use device is intended for use in controlled surgical settings and must be handled under sterile conditions. The clamp is regulated under FDA 510(k) clearance (K955864) and falls under the Orthopedic review panel, adhering to Classification Name Appliance, Fixation, Spinal Interlaminal. No additional sterilization or reprocessing is required as it is designed for one-time use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955864 | Date15 Mar 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from J.B.S., S.A.
Questions
What is the primary purpose of the J.B.S. C1-C2 Clamp in spinal surgery?
The J.B.S. C1-C2 Clamp is designed to provide temporary mechanical stabilization of the C1-C2 vertebrae during orthopedic spinal procedures. Its role is to maintain proper alignment of these vertebrae while facilitating bony fusion, ensuring the spine remains supported until the healing process is complete.
Is the J.B.S. C1-C2 Clamp reusable, or is it intended for single-use only?
The J.B.S. C1-C2 Clamp is explicitly labeled as a single-use device. It is not meant to be reprocessed or reused, as it is intended for controlled surgical settings where sterility must be maintained throughout its use.
How should the J.B.S. C1-C2 Clamp be handled during surgery to ensure sterility?
Since the clamp is a single-use device, it must be handled under sterile conditions throughout the surgical procedure. This includes proper packaging, sterile unpacking, and careful manipulation by surgical staff to prevent contamination.
What regulatory pathway was followed for FDA clearance of this device?
The J.B.S. C1-C2 Clamp received FDA clearance through a traditional 510(k) review process, specifically under the Orthopedic advisory committee (OR) and classified under product code KWP (Appliance, Fixation, Spinal Interlaminal). The clearance decision was made in 1996, confirming it is substantially equivalent to a predicate device.