The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Motionloc Screw For Ncb Polyaxial Locking Plate System.
| Device ID | K123918 |
| 510k Number | K123918 |
| Device Name: | MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER, INC. 345 EAST MAIN ST. Warsaw, IN 46580 |
| Contact | Stephen H Mckelvey, Ma, Rac |
| Correspondent | Stephen H Mckelvey, Ma, Rac ZIMMER, INC. 345 EAST MAIN ST. Warsaw, IN 46580 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-19 |
| Decision Date | 2013-02-14 |
| Summary: | summary |