The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Univers Fracture Prosthesis.
| Device ID | K020345 |
| 510k Number | K020345 |
| Device Name: | ARTHREX UNIVERS FRACTURE PROSTHESIS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Vernon Brown |
| Correspondent | Vernon Brown ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-01 |
| Decision Date | 2002-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888867136489 | K020345 | 000 |
| 00888867057098 | K020345 | 000 |
| 00888867057111 | K020345 | 000 |
| 00888867057135 | K020345 | 000 |
| 00888867057159 | K020345 | 000 |
| 00888867057173 | K020345 | 000 |
| 00888867057685 | K020345 | 000 |
| 00888867057784 | K020345 | 000 |
| 00888867057814 | K020345 | 000 |
| 00888867057845 | K020345 | 000 |
| 00888867057876 | K020345 | 000 |
| 00888867135659 | K020345 | 000 |
| 00888867136434 | K020345 | 000 |
| 00888867057074 | K020345 | 000 |