K872715 is an FDA 510(k) clearance for the UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY. This device is classified as a Implant, Fixation Device, Spinal (Class II — Special Controls, product code JDN).
Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on December 7, 1987, 150 days after receiving the submission on July 10, 1987.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K872715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | July 10, 1987 |
| Decision Date | December 07, 1987 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDN — Implant, Fixation Device, Spinal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3060 |