The following data is part of a premarket notification filed by Nuvasive Specialized Orthopedics, Inc. with the FDA for Precice Unyte Cocr System.
| Device ID | K162927 |
| 510k Number | K162927 |
| Device Name: | PRECICE UNYTE CoCr System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 |
| Contact | Cora Sim |
| Correspondent | Cora Sim NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-19 |
| Decision Date | 2017-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812258027711 | K162927 | 000 |
| 00812258027438 | K162927 | 000 |
| 00812258027445 | K162927 | 000 |
| 00812258027452 | K162927 | 000 |
| 00812258027469 | K162927 | 000 |
| 00812258027476 | K162927 | 000 |
| 00812258027483 | K162927 | 000 |
| 00812258027490 | K162927 | 000 |
| 00812258027506 | K162927 | 000 |
| 00812258027421 | K162927 | 000 |
| 00812258027414 | K162927 | 000 |
| 00812258027339 | K162927 | 000 |
| 00812258027346 | K162927 | 000 |
| 00812258027353 | K162927 | 000 |
| 00812258027360 | K162927 | 000 |
| 00812258027377 | K162927 | 000 |
| 00812258027384 | K162927 | 000 |
| 00812258027391 | K162927 | 000 |
| 00812258027407 | K162927 | 000 |
| 00812258027513 | K162927 | 000 |
| 00812258027520 | K162927 | 000 |
| 00812258027636 | K162927 | 000 |
| 00812258027643 | K162927 | 000 |
| 00812258027650 | K162927 | 000 |
| 00812258027667 | K162927 | 000 |
| 00812258027674 | K162927 | 000 |
| 00812258027681 | K162927 | 000 |
| 00812258027698 | K162927 | 000 |
| 00812258027704 | K162927 | 000 |
| 00812258027629 | K162927 | 000 |
| 00812258027612 | K162927 | 000 |
| 00812258027537 | K162927 | 000 |
| 00812258027544 | K162927 | 000 |
| 00812258027551 | K162927 | 000 |
| 00812258027568 | K162927 | 000 |
| 00812258027575 | K162927 | 000 |
| 00812258027582 | K162927 | 000 |
| 00812258027599 | K162927 | 000 |
| 00812258027605 | K162927 | 000 |
| 00812258027322 | K162927 | 000 |