The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Bone Source Hydroxyapatite.
| Device ID | K970400 |
| 510k Number | K970400 |
| Device Name: | BONE SOURCE HYDROXYAPATITE |
| Classification | Implant, Malar |
| Applicant | ORTHOFIX, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Contact | Mary Biggers |
| Correspondent | Mary Biggers ORTHOFIX, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-05-02 |
| Summary: | summary |