510(k) K112383 ยท MQV Filler, Bone Void, Calcium Compound
CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
| Applicant | Skeletal Kinetics, LLC, Cupertino CA, US |
| Decision | Substantially Equivalent, Feb 7, 2012 |
| Received | Aug 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2020 | Skeletal Kinetics, Llc SKAFFOLD RENU FLOW, 10CC.
Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These d Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc SKAFFOLD RENU FLOW, 5CC.
Product Number: SKMA-FL05, UDI: 813845020849 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These de Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc EXACTECH OSSILIX MP FIL, 10CC.
Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Th Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.