The following data is part of a premarket notification filed by Osteogenics, Inc. with the FDA for Bonesource Hydroxyapatite Cement (hac).
| Device ID | K964537 |
| 510k Number | K964537 |
| Device Name: | BONESOURCE HYDROXYAPATITE CEMENT (HAC) |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | OSTEOGENICS, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Contact | Mary Biggers |
| Correspondent | Mary Biggers OSTEOGENICS, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-12 |
| Decision Date | 1997-01-24 |
| Summary: | summary |