K101848 is an FDA 510(k) clearance for the SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 14, 2010, 105 days after receiving the submission on July 1, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K101848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2010 |
| Decision Date | October 14, 2010 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWQ — Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |