TRANS-ORAL DEPTH GAUGE
FDA 510(k) clearance K893415 · decided 1989-06-07
Clearance details
- K-number
- K893415
- Device name
- TRANS-ORAL DEPTH GAUGE
- Applicant
- Ruggles Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-02
- Decision date
- 1989-06-07
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- LYQ
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- No. Quincy, MA, 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 |
|---|---|---|
| TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE (K883784) | Warsaw Orthopedic, Inc. | 1989-04-06 |
| CASF DRILL GUIDE DG 170 (K882871) | Terray Manufacturing, Inc. | 1988-09-23 |
Recalls involving this device
No recalls on record reference this clearance.