The following data is part of a premarket notification filed by Nuvasive Specialized Orthopedics, Incorporated with the FDA for Supplemental Instrument Trays.
| Device ID | K170939 |
| 510k Number | K170939 |
| Device Name: | Supplemental Instrument Trays |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | NuVasive Specialized Orthopedics, Incorporated 101 Enterprise Aliso Viejo, CA 92656 |
| Contact | Cora Sim |
| Correspondent | Cora Sim NuVasive Specialized Orthopedics, Incorporated 101 Enterprise Aliso Viejo, CA 92656 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-30 |
| Decision Date | 2017-08-08 |
| Summary: | summary |