BACFIX SPINAL FIXATION SYSTEM
FDA 510(k) clearance K964404 · decided 1997-03-26
Clearance details
- K-number
- K964404
- Device name
- BACFIX SPINAL FIXATION SYSTEM
- Applicant
- Spinal Concepts, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1996-11-04
- Decision date
- 1997-03-26
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- KWP
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas recall (Z-0920-04) | Spinal Concepts, Inc | 2004-07-20 |