The following data is part of a premarket notification filed by Newclip Technics with the FDA for Activmotion S Dto.
| Device ID | K202803 |
| 510k Number | K202803 |
| Device Name: | Activmotion S DTO |
| Classification | Plate, Fixation, Bone |
| Applicant | Newclip Technics PA De La Lande Saint 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 | 2020-09-23 |
| Decision Date | 2021-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700569654702 | K202803 | 000 |
| 03700569654405 | K202803 | 000 |
| 03700569654429 | K202803 | 000 |
| 03700569654443 | K202803 | 000 |
| 03700569654467 | K202803 | 000 |
| 03700569654481 | K202803 | 000 |
| 03700569654504 | K202803 | 000 |
| 03700569654528 | K202803 | 000 |
| 03700569654542 | K202803 | 000 |
| 03700569654566 | K202803 | 000 |
| 03700569654580 | K202803 | 000 |
| 03700569654603 | K202803 | 000 |
| 03700569654627 | K202803 | 000 |
| 03700569654665 | K202803 | 000 |
| 03700569654689 | K202803 | 000 |
| 03700569654399 | K202803 | 000 |