TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
FDA 510(k) clearance K883784 · decided 1989-04-06
Clearance details
- K-number
- K883784
- Device name
- TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
- Applicant
- Warsaw Orthopedic, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1988-09-06
- Decision date
- 1989-04-06
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- LYQ
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, 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 |
|---|---|---|
| TRANS-ORAL DEPTH GAUGE (K893415) | Ruggles Corp. | 1989-06-07 |
| CASF DRILL GUIDE DG 170 (K882871) | Terray Manufacturing, Inc. | 1988-09-23 |
Recalls involving this device
No recalls on record reference this clearance.