The following data is part of a premarket notification filed by Extremity Medical Llc with the FDA for Extremity Medical Calcaneal Osteotomy Device.
| Device ID | K143402 |
| 510k Number | K143402 |
| Device Name: | Extremity Medical Calcaneal Osteotomy Device |
| Classification | Screw, Fixation, Bone |
| Applicant | EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany, NJ 07054 |
| Contact | Brian Smekal |
| Correspondent | Brian Smekal EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany, NJ 07054 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-28 |
| Decision Date | 2015-02-04 |
| Summary: | summary |