The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Total Ossicular Replacement.
| Device ID | K823919 |
| 510k Number | K823919 |
| Device Name: | TOTAL OSSICULAR REPLACEMENT |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-28 |
| Decision Date | 1983-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490195775 | K823919 | 000 |
| 00681490195768 | K823919 | 000 |
| 00681490035781 | K823919 | 000 |
| 00681490035774 | K823919 | 000 |
| 00681490035705 | K823919 | 000 |
| 00681490035699 | K823919 | 000 |