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 |