K100061 is an FDA 510(k) clearance for the CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on February 12, 2010, 32 days after receiving the submission on January 11, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K100061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2010 |
| Decision Date | February 12, 2010 |
| Days to Decision | 32 days |
| Submission Type | Special |
| 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 |