The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Univers Apex.
| Device ID | K131633 |
| 510k Number | K131633 |
| Device Name: | ARTHREX UNIVERS APEX |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-04 |
| Decision Date | 2013-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888867213524 | K131633 | 000 |
| 00888867134454 | K131633 | 000 |
| 00888867134508 | K131633 | 000 |
| 00888867134553 | K131633 | 000 |
| 00888867134607 | K131633 | 000 |
| 00888867134652 | K131633 | 000 |
| 00888867134706 | K131633 | 000 |
| 00888867134751 | K131633 | 000 |
| 00888867134799 | K131633 | 000 |
| 00888867134836 | K131633 | 000 |
| 00888867134416 | K131633 | 000 |