The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Peri-loc Periarticular Locked Plating System Volar Distal Radius Locking Plate For The Upper Extremity-astm F139.
| Device ID | K081106 |
| 510k Number | K081106 |
| Device Name: | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139 |
| Classification | Plate, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Laura Sejnowski |
| Correspondent | Laura Sejnowski SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-18 |
| Decision Date | 2008-06-18 |
| Summary: | summary |