The following data is part of a premarket notification filed by Nuvasive Specialized Orthopedics, Inc. with the FDA for Precice System.
| Device ID | K191336 |
| 510k Number | K191336 |
| Device Name: | PRECICE System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 |
| Contact | Aditya Sharma |
| Correspondent | Aditya Sharma 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 | 2019-05-17 |
| Decision Date | 2019-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517014979 | K191336 | 000 |
| 00887517059499 | K191336 | 000 |
| 00887517059444 | K191336 | 000 |
| 00887517059437 | K191336 | 000 |
| 00195377083302 | K191336 | 000 |
| 00195377024343 | K191336 | 000 |