The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Radial Nail System.
| Device ID | K040938 |
| 510k Number | K040938 |
| Device Name: | RADIAL NAIL SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Ehab Esmail |
| Correspondent | Ehab Esmail 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 | 2004-04-12 |
| Decision Date | 2004-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420192196 | K040938 | 000 |
| 00840420190932 | K040938 | 000 |
| 00840420190949 | K040938 | 000 |
| 00840420190956 | K040938 | 000 |
| 00840420190963 | K040938 | 000 |
| 00840420192158 | K040938 | 000 |
| 00840420192165 | K040938 | 000 |
| 00840420192172 | K040938 | 000 |
| 00840420192189 | K040938 | 000 |
| 00840420134868 | K040938 | 000 |