510(k) K100986 ยท MQV Filler, Bone Void, Calcium Compound
CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
| Applicant | Skeletal Kinetics, LLC, Cupertino CA, US |
| Decision | Substantially Equivalent, Jul 20, 2010 |
| Received | Apr 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100986
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2020 | Osteomed, LLC OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | None listed |
| May 29, 2020 | Osteomed, LLC OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc ACUMED IMPACT 10CC.
Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgica Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc ACUMED IMPACT 5CC.
Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc EXACTECH OSSILIX FORM (MX), 10CC.
Product Number: 660-01-10, UDI: 813845021037 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc EXACTECH OSSILIX FORM (MX), 5CC.
Product Number: 660-01-05, UDI: 813845021020 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc OSTEOVATION EX, 3CC, IMPACT FORMULA.
Product Number: 390-0203, UDI: 813845020030 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc OSTEOVATION EX, 5CC, IMPACT FORMULA.
Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc SK SKAFFOLD IMPRESS 10CC.
Product Number: SKAF-IM10, UDI: 813845020795 - 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 CMF IMPRESS (MP), 10CC.
Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc SKAFFOLD CMF IMPRESS (MP), 5CC.
Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). T Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.