The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Mcgee Modified Stainless Steel Piston.
| Device ID | K823440 |
| 510k Number | K823440 |
| Device Name: | MCGEE MODIFIED STAINLESS STEEL PISTON |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETB |
| 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 |
|---|---|---|
| 00681490035682 | K823440 | 000 |
| 00681490035569 | K823440 | 000 |
| 00681490035200 | K823440 | 000 |
| 00681490035194 | K823440 | 000 |
| 00681490035187 | K823440 | 000 |
| 00681490035170 | K823440 | 000 |
| 20681490035211 | K823440 | 000 |
| 00763000039806 | K823440 | 000 |
| 00763000035341 | K823440 | 000 |
| 00763000035334 | K823440 | 000 |
| 00681490035576 | K823440 | 000 |
| 00681490035583 | K823440 | 000 |
| 00681490035675 | K823440 | 000 |
| 00681490035668 | K823440 | 000 |
| 00681490035651 | K823440 | 000 |
| 00681490035644 | K823440 | 000 |
| 00681490035637 | K823440 | 000 |
| 00681490035620 | K823440 | 000 |
| 00681490035613 | K823440 | 000 |
| 00681490035606 | K823440 | 000 |
| 00681490035590 | K823440 | 000 |
| 00763000035310 | K823440 | 000 |