The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Peri-loc Locking Hole Inserts And Cable Accessories.
| Device ID | K100325 |
| 510k Number | K100325 |
| Device Name: | PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Laura Medlin |
| Correspondent | Laura Medlin SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-04 |
| Decision Date | 2010-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556142417 | K100325 | 000 |
| 00885556138953 | K100325 | 000 |
| 00885556138946 | K100325 | 000 |
| 00885556138939 | K100325 | 000 |
| 00885556138922 | K100325 | 000 |