510(k) K162864 ยท GXP Methyl Methacrylate For Cranioplasty
OsteoVation Impact
| Applicant | Skeletal Kinetics, LLC, Cupertino CA, US |
| Decision | Substantially Equivalent, Jan 13, 2017 |
| Received | Oct 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162864
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT C, 10CC.
Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT C, 3CC.
Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects m Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT C, 5CC.
Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT, CMF IMPACT, 3CC
Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Thes Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT, CMF IMPACT, 5CC,
Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). The Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT, CMF IMPACT, 10CC,
Product Number: C-CMF10CC, UDI: 813845020955 - 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 3, 2020 | Skeletal Kinetics, Llc Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, o Terminated |
GXP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.