The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Motionloc Screw For Ncb Polyaxial Locking Plating System.
Device ID | K101696 |
510k Number | K101696 |
Device Name: | MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Stephen G Mckelvey, Ma, Rac |
Correspondent | Stephen G Mckelvey, Ma, Rac ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-16 |
Decision Date | 2010-09-10 |
Summary: | summary |