The following data is part of a premarket notification filed by Newclip Technics with the FDA for Activmotion Range.
| Device ID | K173746 |
| 510k Number | K173746 |
| Device Name: | Activmotion Range |
| Classification | Plate, Fixation, Bone |
| Applicant | Newclip Technics Pa De La Lande Sanit Martin 45 Rue Des Garottieres Haute-goulaine, FR 44115 |
| Contact | Gaelle Lussori |
| Correspondent | J D Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-08 |
| Decision Date | 2018-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700569627669 | K173746 | 000 |
| 03700569627652 | K173746 | 000 |
| 03700569617608 | K173746 | 000 |
| 03700569617592 | K173746 | 000 |
| 03700569602499 | K173746 | 000 |
| 03700569602475 | K173746 | 000 |