The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Locon Vls Distal Radius Plate System.
| Device ID | K042358 |
| 510k Number | K042358 |
| Device Name: | LOCON VLS DISTAL RADIUS PLATE SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Jeanine H Redden |
| Correspondent | Jeanine H Redden WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-31 |
| Decision Date | 2004-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420134851 | K042358 | 000 |
| 00840420134394 | K042358 | 000 |
| 00840420134400 | K042358 | 000 |
| 00840420134417 | K042358 | 000 |
| 00840420134714 | K042358 | 000 |
| 00840420134721 | K042358 | 000 |
| 00840420134738 | K042358 | 000 |
| 00840420134745 | K042358 | 000 |
| 00840420134752 | K042358 | 000 |
| 00840420134769 | K042358 | 000 |
| 00840420134776 | K042358 | 000 |
| 00840420134783 | K042358 | 000 |
| 00840420134790 | K042358 | 000 |
| 00840420134806 | K042358 | 000 |
| 00840420134813 | K042358 | 000 |
| 00840420134820 | K042358 | 000 |
| 00840420134837 | K042358 | 000 |
| 00840420134844 | K042358 | 000 |
| 00840420134387 | K042358 | 000 |