The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Wmt Modular Ulnar Head Implant.
| Device ID | K020274 |
| 510k Number | K020274 |
| Device Name: | WMT MODULAR ULNAR HEAD IMPLANT |
| Classification | Prosthesis, Wrist, Hemi-, Ulnar |
| 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 | KXE |
| CFR Regulation Number | 888.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-28 |
| Decision Date | 2002-02-22 |
| Summary: | summary |