The following data is part of a premarket notification filed by Skeletal Kinetics, Llc with the FDA for Callos Impact And Inject Bone Void Filler.
| Device ID | K051123 |
| 510k Number | K051123 |
| Device Name: | CALLOS IMPACT AND INJECT BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| 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 | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-03 |
| Decision Date | 2005-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169110267 | K051123 | 000 |
| 00643169168404 | K051123 | 000 |
| 00643169168398 | K051123 | 000 |