KAMBIN LAMINECTOMY FRAME
FDA 510(k) clearance K874494 · decided 1987-11-23
Clearance details
- K-number
- K874494
- Device name
- KAMBIN LAMINECTOMY FRAME
- Applicant
- Avec Scientific Design Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-02
- Decision date
- 1987-11-23
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- LWG
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Philadelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHOP SPINE FRAME (K883295) | Avec Scientific Design Corp. | 1988-08-23 |
| SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS (K882520) | Karlin Technology, Inc. | 1988-07-18 |
| CEDAR(TM) PELVIC CUSHION (K873690) | Cedar Surgical, Inc. | 1987-10-26 |
Recalls involving this device
No recalls on record reference this clearance.