K970400 is an FDA 510(k) clearance for the BONE SOURCE HYDROXYAPATITE. This device is classified as a Implant, Malar (Class II - Special Controls, product code LZK).
Submitted by Orthofix, Inc. (Richardson, US). The FDA issued a Cleared decision on May 2, 1997, 88 days after receiving the submission on February 3, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K970400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1997 |
| Decision Date | May 02, 1997 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LZK — Implant, Malar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3550 |