The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Locon-t Distal Radial Plate.
| Device ID | K994061 |
| 510k Number | K994061 |
| Device Name: | LOCON-T DISTAL RADIAL PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Lynne Witkowski |
| Correspondent | Lynne Witkowski WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-01 |
| Decision Date | 2000-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420133397 | K994061 | 000 |
| 00840420133236 | K994061 | 000 |
| 00840420133229 | K994061 | 000 |
| 00840420133021 | K994061 | 000 |
| 00840420133014 | K994061 | 000 |
| 00840420133007 | K994061 | 000 |
| 00840420132994 | K994061 | 000 |
| 00840420132987 | K994061 | 000 |
| 00840420132970 | K994061 | 000 |
| 00840420132963 | K994061 | 000 |
| 00840420132956 | K994061 | 000 |
| 00840420132703 | K994061 | 000 |
| 00840420132697 | K994061 | 000 |
| 00840420133243 | K994061 | 000 |
| 00840420133250 | K994061 | 000 |
| 00840420133267 | K994061 | 000 |
| 00840420133380 | K994061 | 000 |
| 00840420133373 | K994061 | 000 |
| 00840420133366 | K994061 | 000 |
| 00840420133359 | K994061 | 000 |
| 00840420133342 | K994061 | 000 |
| 00840420133335 | K994061 | 000 |
| 00840420133328 | K994061 | 000 |
| 00840420133311 | K994061 | 000 |
| 00840420133304 | K994061 | 000 |
| 00840420133298 | K994061 | 000 |
| 00840420133281 | K994061 | 000 |
| 00840420133274 | K994061 | 000 |
| 00840420132680 | K994061 | 000 |