K013764 is an FDA 510(k) clearance for the IMMIX BONE GRAFT EXTENDER. This device is classified as a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II - Special Controls, product code KKY).
Submitted by Osteogenics Biomedical, Inc. (Fort Worth, US). The FDA issued a Cleared decision on May 16, 2002, 184 days after receiving the submission on November 13, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3500.
| 510(k) Number | K013764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2001 |
| Decision Date | May 16, 2002 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KKY - Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3500 |