The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Interpore 200 Porous Hydroxyapatite.
| Device ID | K860983 |
| 510k Number | K860983 |
| Device Name: | INTERPORE 200 POROUS HYDROXYAPATITE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-17 |
| Decision Date | 1986-05-23 |