The following data is part of a premarket notification filed by Skeletal Kinetics, Llc with the FDA for Callos Cmf Bone Void Filler.
| Device ID | K042072 |
| 510k Number | K042072 |
| Device Name: | CALLOS CMF BONE VOID FILLER |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | SKELETAL KINETICS, LLC 10201 BUBB RD. Cupertino, CA 95014 -4167 |
| Contact | Duran Yetkinler |
| Correspondent | Duran Yetkinler SKELETAL KINETICS, LLC 10201 BUBB RD. Cupertino, CA 95014 -4167 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-02 |
| Decision Date | 2004-09-16 |
| Summary: | summary |