The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Craniofacial Calcium Phosphate Ceramic Bone Filler.
| Device ID | K990290 |
| 510k Number | K990290 |
| Device Name: | CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Michelle L Mckinley |
| Correspondent | Michelle L Mckinley BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-29 |
| Decision Date | 1999-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036021009 | K990290 | 000 |
| 00841036020996 | K990290 | 000 |
| 00841036020965 | K990290 | 000 |