K111008 is an FDA 510(k) clearance for the MICROWARE BONE PLATES AND BONE SCREW. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Microware Precision Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on May 2, 2012, 387 days after receiving the submission on April 11, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K111008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2011 |
| Decision Date | May 02, 2012 |
| Days to Decision | 387 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS - Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |