The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Tie-in Trapezium.
| Device ID | K033529 |
| 510k Number | K033529 |
| Device Name: | TIE-IN TRAPEZIUM |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Katie Logerot |
| Correspondent | Katie Logerot WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-10 |
| Decision Date | 2003-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420121844 | K033529 | 000 |
| 00840420121837 | K033529 | 000 |
| 00840420121820 | K033529 | 000 |
| 00840420199522 | K033529 | 000 |
| 00840420189936 | K033529 | 000 |
| 00840420189929 | K033529 | 000 |
| 00840420189912 | K033529 | 000 |
| 00840420189905 | K033529 | 000 |
| 00840420189899 | K033529 | 000 |