K170939 is an FDA 510(k) clearance for the Supplemental Instrument Trays. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Nuvasive Specialized Orthopedics, Incorporated (Aliso Viejo, US). The FDA issued a Cleared decision on August 8, 2017, 131 days after receiving the submission on March 30, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K170939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2017 |
| Decision Date | August 08, 2017 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |