510(k) K051123 ยท MQV Filler, Bone Void, Calcium Compound
CALLOS IMPACT AND INJECT BONE VOID FILLER
| Applicant | Skeletal Kinetics, LLC, Cupertino CA, US |
| Decision | Substantially Equivalent, Jun 3, 2005 |
| Received | May 3, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051123
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2020 | Osteomed, LLC OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - 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 INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - 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 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - 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 INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - 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 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - 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 CALLOS INJECT 10CC.
Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc ACUMED CALLOS INJECT 3CC.
Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc ACUMED CALLOS INJECT 5CC.
Product Number: 65-0005-S, UDI: 813845020238 - 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 EXACTECH OSSILIX FIL (MX), 10CC.
Product Number: 660-02-10, UDI: 813845021013 - - 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 FIL (MX), 5CC.
Product Number: 660-02-05, UDI: 813845021006 - 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 |
| Apr 6, 2020 | Skeletal Kinetics, Llc MEDTRONIC BONE VOID FILLER, LARGE.
Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). The Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc MEDTRONIC BONE VOID FILLER, SMALL.
Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). The Terminated |
MQV | None listed |
| Apr 6, 2020 | Skeletal Kinetics, Llc OSTEOVATION, 5CC, INJECT FORMULA.
Product Number: 390-2005, UDI: 813845020054 - 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 OSTEOVATIONEX 2CC INJECT FORMULA.
Product Number: 390-0002, UDI: 813845020009 - 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 OSTEOVATIONEX 5CC, INJECT FORMULA.
Product Number: 390-0005, UDI: 813845020023 - 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 OSTEOVATIONEX, INJECT 3CC.
Product Number: 390-0003, UDI: 813845020016 - 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 |
| Jul 24, 2015 | Skeletal Kinetics, Llc InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.