510(k) K042072 ยท GXP Methyl Methacrylate For Cranioplasty
CALLOS CMF BONE VOID FILLER
| Applicant | Skeletal Kinetics, LLC, Cupertino CA, US |
| Decision | Substantially Equivalent, Sep 16, 2004 |
| Received | Aug 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, 3CC.
Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These d Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, 10CC.
Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, CAN, 5CC.
Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, OUS, 10CC.
Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis) Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, OUS, 5CC
Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). T Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT, FLOW 5CC.
Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These def Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC.
Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, sp Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc SKAFFOLD FLOW (MX) 5CC.
Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These def Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc SKAFFOLD FLOW, 10CC.
Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defect Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, CAN, 10CC,
Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis) Terminated |
GXP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.