The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Peri-loc Locking Bone Plates And Locking Bone Screws For The Upper Extremity.
| Device ID | K051735 |
| 510k Number | K051735 |
| Device Name: | PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY |
| Classification | Plate, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | KTT |
| Subsequent Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-28 |
| Decision Date | 2005-07-19 |
| Summary: | summary |