The following data is part of a premarket notification filed by Ascension Orthopedic with the FDA for Nugait(tm) Subtalar Implant System.
| Device ID | K111799 |
| 510k Number | K111799 |
| Device Name: | NUGAIT(TM) SUBTALAR IMPLANT SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754 |
| Contact | Bradley W Strasser |
| Correspondent | Bradley W Strasser ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-08-19 |
| Summary: | summary |