The following data is part of a premarket notification filed by Newclip Technics with the FDA for Foot And Hand Motion System.
Device ID | K091118 |
510k Number | K091118 |
Device Name: | FOOT AND HAND MOTION SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | NEWCLIP TECHNICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
Contact | J.d. Webb |
Correspondent | J.d. Webb NEWCLIP TECHNICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-17 |
Decision Date | 2009-12-16 |