The following data is part of a premarket notification filed by Nutek Orthopaedics, Inc. with the FDA for Nbx - Non-bridging External Fixator - Shoulder.
| Device ID | K082833 |
| 510k Number | K082833 |
| Device Name: | NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | NUTEK ORTHOPAEDICS, INC. 16771 SW 6TH ST. Pembroke Pines, FL 33027 |
| Contact | Peter Mincielli |
| Correspondent | Peter Mincielli NUTEK ORTHOPAEDICS, INC. 16771 SW 6TH ST. Pembroke Pines, FL 33027 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-26 |
| Decision Date | 2009-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B488810700000 | K082833 | 000 |