The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Micronail Distal Radius System.
| Device ID | K150073 |
| 510k Number | K150073 |
| Device Name: | MICRONAIL Distal Radius System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Jeanine Redden |
| Correspondent | Jeanine Redden Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-14 |
| Decision Date | 2015-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420123787 | K150073 | 000 |
| 00840420118943 | K150073 | 000 |
| 00840420118950 | K150073 | 000 |
| 00840420118967 | K150073 | 000 |
| 00840420118974 | K150073 | 000 |
| 00840420118981 | K150073 | 000 |
| 00840420118998 | K150073 | 000 |
| 00840420119001 | K150073 | 000 |
| 00840420119018 | K150073 | 000 |
| 00840420119025 | K150073 | 000 |
| 00840420119032 | K150073 | 000 |
| 00840420119049 | K150073 | 000 |
| 00840420119056 | K150073 | 000 |
| 00840420123749 | K150073 | 000 |
| 00840420123756 | K150073 | 000 |
| 00840420123763 | K150073 | 000 |
| 00840420123770 | K150073 | 000 |
| 00840420118936 | K150073 | 000 |