The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Austin Modified Total Ossicular Replace.
| Device ID | K823441 |
| 510k Number | K823441 |
| Device Name: | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE |
| Classification | Porous Polyethylene Ossicular Replacement |
| Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBM |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-16 |
| Decision Date | 1982-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490035712 | K823441 | 000 |
| 00681490035477 | K823441 | 000 |
| 00763000035440 | K823441 | 000 |
| 00763000035396 | K823441 | 000 |