The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Wmt Ultra-fit Modular Shoulder System.
| Device ID | K002683 |
| 510k Number | K002683 |
| Device Name: | WMT ULTRA-FIT MODULAR SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Ehab M Esmail |
| Correspondent | Ehab M Esmail WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-28 |
| Decision Date | 2000-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420189011 | K002683 | 000 |
| 00840420188915 | K002683 | 000 |
| 00840420188922 | K002683 | 000 |
| 00840420188939 | K002683 | 000 |
| 00840420188946 | K002683 | 000 |
| 00840420188953 | K002683 | 000 |
| 00840420188960 | K002683 | 000 |
| 00840420188977 | K002683 | 000 |
| 00840420188984 | K002683 | 000 |
| 00840420188991 | K002683 | 000 |
| 00840420189004 | K002683 | 000 |
| 00840420188908 | K002683 | 000 |