510(k) K051784 ยท GXP Methyl Methacrylate For Cranioplasty
OSTEOVATION CMF BONE VOID FILLER
| Applicant | Skeletal Kinetics, LLC, Cupertino CA, US |
| Decision | Substantially Equivalent, Jul 20, 2005 |
| Received | Jul 1, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051784
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2020 | Osteomed, LLC OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - 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 OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - 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 OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - 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 OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - 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 OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - 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 OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110,
UDI: 813845020092 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. Terminated |
GXP | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc OSTEOVATION RMX 10CC.
Product Number: 390-6002, UDI: 813845021099 - 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 OSTEOVATION RMX 5CC.
Product Number: 390-6001, UDI: 813845021082 - 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 OSTEOVATION, 10CC, INJECT FORMULA.
Product Number: 390-2010, UDI: 813845020061 - 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 OSTEOVATION, 3CC, IMPACT FORMULA.
Product Number: 390-2103, UDI: 813845020078 - 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 OSTEOVATION, 5CC, IMPACT FORMULA.
Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Terminated |
GXP | None listed |
| Jun 6, 2019 | Skeletal Kinetics, Llc OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing Terminated |
GXP | None listed |
| Jun 6, 2019 | Skeletal Kinetics, Llc OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing proces Terminated |
GXP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.