AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
FDA 510(k) clearance K823441 · decided 1982-12-03
Clearance details
- K-number
- K823441
- Device name
- AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-16
- Decision date
- 1982-12-03
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- LBM
- Device class
- 2
- Regulation number
- 874.3450
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, 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 |
|---|---|---|
| FISCH MODIFIED TOTAL OSSICULAR PROSTHES (K823442) | Treace Medical, Inc. | 1982-12-03 |
Recalls involving this device
No recalls on record reference this clearance.