The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Peri-loc Periarticular Locked Plating System.
| Device ID | K071563 |
| 510k Number | K071563 |
| Device Name: | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-07 |
| Decision Date | 2007-08-08 |
| Summary: | summary |