ASST-3000 SPINAL SURGERY TABLE
FDA 510(k) clearance K883457 · decided 1988-08-26
Clearance details
- K-number
- K883457
- Device name
- ASST-3000 SPINAL SURGERY TABLE
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-12
- Decision date
- 1988-08-26
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- FWY
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Orthopedic Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SKYTRON MODEL 130 SURGICAL TABLE (K873478) | Skytron, Div. the Kmw Group, Inc. | 1987-09-24 |
| CHEMONUCLEOLYSIS TABLE (K833509) | Stryker Corp. | 1983-11-28 |
| CHICK SURGICAL TABLE (K800118) | Warner-Lambert Co. | 1980-02-05 |
Recalls involving this device
No recalls on record reference this clearance.