The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Univers 30 Shoulder Prosthesis.
| Device ID | K010124 |
| 510k Number | K010124 |
| Device Name: | ARTHREX UNIVERS 30 SHOULDER 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 | 2001-01-16 |
| Decision Date | 2001-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888867136151 | K010124 | 000 |
| 00888867136014 | K010124 | 000 |
| 00888867135642 | K010124 | 000 |
| 00888867135543 | K010124 | 000 |
| 00888867135468 | K010124 | 000 |
| 00888867057265 | K010124 | 000 |
| 00888867057258 | K010124 | 000 |
| 00888867057241 | K010124 | 000 |
| 00888867057234 | K010124 | 000 |
| 00888867057227 | K010124 | 000 |
| 00888867057210 | K010124 | 000 |
| 00888867136113 | K010124 | 000 |
| 00888867136229 | K010124 | 000 |
| 00888867134676 | K010124 | 000 |
| 00888867134522 | K010124 | 000 |
| 00888867134478 | K010124 | 000 |
| 00888867134430 | K010124 | 000 |
| 00888867057302 | K010124 | 000 |
| 00888867057296 | K010124 | 000 |
| 00888867057289 | K010124 | 000 |
| 00888867136472 | K010124 | 000 |
| 00888867136427 | K010124 | 000 |
| 00888867136328 | K010124 | 000 |
| 00888867134621 | K010124 | 000 |