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 |