The following data is part of a premarket notification filed by Innovision, Inc. with the FDA for N-force Fixation System.
Device ID | K151146 |
510k Number | K151146 |
Device Name: | N-Force Fixation System |
Classification | Screw, Fixation, Bone |
Applicant | INNOVISION, INC. 1975 NONCONNAH BLVD. Memphis, TN 38132 |
Contact | Keith Russell |
Correspondent | Hollace Saas Rhodes MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS LLC 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-29 |
Decision Date | 2015-07-24 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
N-FORCE FIXATION SYSTEM 85236050 4050880 Live/Registered |
INNOVISION, INC. 2011-02-07 |
N-FORCE FIXATION SYSTEM 85135460 not registered Dead/Abandoned |
Innovision, Inc 2010-09-22 |