The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Motionloc Screw For Periarticular Locking Plate System.
| Device ID | K130810 |
| 510k Number | K130810 |
| Device Name: | ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | ZIMMER, INC. 9001 WESLEYAN ROAD, STE 200 Indianapolis, IN 46268 |
| Contact | Scott M Durlacher |
| Correspondent | Scott M Durlacher ZIMMER, INC. 9001 WESLEYAN ROAD, STE 200 Indianapolis, IN 46268 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-25 |
| Decision Date | 2013-09-19 |
| Summary: | summary |