The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Vlp 2.7mm Extra Large Percutaneous Calcaneus Plate, Peri-loc 3.5mm Anterior Ankle Fusion Plates, Peri-loc 3.5mm Hindfoot.
| Device ID | K120667 |
| 510k Number | K120667 |
| Device Name: | VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT |
| 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 |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-05 |
| Decision Date | 2012-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556279267 | K120667 | 000 |
| 00885556279212 | K120667 | 000 |
| 00885556279014 | K120667 | 000 |
| 00885556278963 | K120667 | 000 |
| 00885556278918 | K120667 | 000 |
| 00885556278864 | K120667 | 000 |
| 00885556278819 | K120667 | 000 |
| 00885556278765 | K120667 | 000 |
| 00885556278666 | K120667 | 000 |