The following data is part of a premarket notification filed by Newclip Technics with the FDA for Alians Fragment Specific.
Device ID | K170843 |
510k Number | K170843 |
Device Name: | Alians Fragment Specific |
Classification | Plate, Fixation, Bone |
Applicant | Newclip Technics PA De La Lande Saint Martin - 45 Rue Des Garottieres Haute-goulaine, FR 44 115 |
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 | 2017-03-21 |
Decision Date | 2017-06-16 |
Summary: | summary |