The following data is part of a premarket notification filed by Nutek Orthopaedics, Inc. with the FDA for Nbx - Non Bridging External Fixator Hand.
| Device ID | K122777 |
| 510k Number | K122777 |
| Device Name: | NBX - NON BRIDGING EXTERNAL FIXATOR HAND |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | NUTEK ORTHOPAEDICS, INC. 301 S.W. 7TH ST. Ft. Lauderdale, FL 33315 |
| Contact | Peter Mincieli |
| Correspondent | Peter Mincieli NUTEK ORTHOPAEDICS, INC. 301 S.W. 7TH ST. Ft. Lauderdale, FL 33315 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-11 |
| Decision Date | 2013-05-15 |
| Summary: | summary |