The following data is part of a premarket notification filed by Newclip Technics with the FDA for Xpert Wrist.
| Device ID | K213214 |
| 510k Number | K213214 |
| Device Name: | Xpert Wrist |
| Classification | Plate, Fixation, Bone |
| Applicant | Newclip Technics P.A. De La Lande Saint Martin - 45 Rue Des Garottieres Haute-goulaine, FR F-44115 |
| Contact | Gregoire Larche |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, UT 84401 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2021-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700569654382 | K213214 | 000 |
| 03700569642372 | K213214 | 000 |
| 03700569642365 | K213214 | 000 |
| 03700569642358 | K213214 | 000 |
| 03700569642341 | K213214 | 000 |
| 03700569642334 | K213214 | 000 |
| 03700569642327 | K213214 | 000 |
| 03700569642310 | K213214 | 000 |
| 03700569642303 | K213214 | 000 |
| 03700569642297 | K213214 | 000 |
| 03700569642280 | K213214 | 000 |
| 03700569642389 | K213214 | 000 |
| 03700569642396 | K213214 | 000 |
| 03700569654375 | K213214 | 000 |
| 03700569654368 | K213214 | 000 |
| 03700569654351 | K213214 | 000 |
| 03700569654344 | K213214 | 000 |
| 03700569654337 | K213214 | 000 |
| 03700569654320 | K213214 | 000 |
| 03700569654313 | K213214 | 000 |
| 03700569654306 | K213214 | 000 |
| 03700569654290 | K213214 | 000 |
| 03700569642402 | K213214 | 000 |
| 03700569642273 | K213214 | 000 |