The following data is part of a premarket notification filed by Skeletal Kinetics, Llc with the FDA for Callos Promodel Bone Void Filler, Skaffold Mp (macro Porous) Bone Void Filler.
| Device ID | K112383 |
| 510k Number | K112383 |
| Device Name: | CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SKELETAL KINETICS, LLC 10201 BUBB RD. Cupertino, CA 95014 -4167 |
| Contact | Christine Kuo |
| Correspondent | Christine Kuo SKELETAL KINETICS, LLC 10201 BUBB RD. Cupertino, CA 95014 -4167 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-18 |
| Decision Date | 2012-02-07 |
| Summary: | summary |