K113648 is an FDA 510(k) clearance for the LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Aap Implantate AG (Berlin, DE). The FDA issued a Cleared decision on September 6, 2012, 269 days after receiving the submission on December 12, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K113648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2011 |
| Decision Date | September 06, 2012 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| 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 |