The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Bucket Prosthesis Porp.
| Device ID | K883727 |
| 510k Number | K883727 |
| Device Name: | BUCKET PROSTHESIS PORP |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
| Contact | Thomas, Jr |
| Correspondent | Thomas, Jr TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-31 |
| Decision Date | 1989-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490035859 | K883727 | 000 |
| 00763000035525 | K883727 | 000 |
| 00763000035532 | K883727 | 000 |
| 00763000035549 | K883727 | 000 |
| 00763000035556 | K883727 | 000 |
| 00763000035563 | K883727 | 000 |
| 00681490034593 | K883727 | 000 |
| 00681490035804 | K883727 | 000 |
| 00681490035811 | K883727 | 000 |
| 00681490035828 | K883727 | 000 |
| 00681490035835 | K883727 | 000 |
| 00681490035842 | K883727 | 000 |
| 00763000035518 | K883727 | 000 |