The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Peri-loc Proximal Femur Locking Bone Plates.
| Device ID | K112406 |
| 510k Number | K112406 |
| Device Name: | PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 7135 GOODLET FARMS PARKWAY Cordova, TN 38016 |
| Contact | David Henly |
| Correspondent | David Henly SMITH & NEPHEW, INC. 7135 GOODLET FARMS PARKWAY Cordova, TN 38016 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2011-11-14 |
| Summary: | summary |