The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Osteocure Resorbable Bead Kit.
| Device ID | K051406 |
| 510k Number | K051406 |
| Device Name: | OSTEOCURE RESORBABLE BEAD KIT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NEXA ORTHOPEDICS, INC. 990 PARK CENTER DR., SUITE H Vista, CA 92081 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht NEXA ORTHOPEDICS, INC. 990 PARK CENTER DR., SUITE H Vista, CA 92081 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-31 |
| Decision Date | 2005-08-01 |
| Summary: | summary |