The following data is part of a premarket notification filed by Medicrea with the FDA for Osmosys Calcium Phosphate Ceramic Bone Filler.
| Device ID | K050490 |
| 510k Number | K050490 |
| Device Name: | OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | MEDICREA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb MEDICREA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-25 |
| Decision Date | 2005-04-11 |
| Summary: | summary |