Atlas FDA

CALLOS IMPACT AND INJECT BONE VOID FILLER

FDA 510(k) clearance K051123 · decided 2005-06-03

Clearance details

K-number
K051123
Device name
CALLOS IMPACT AND INJECT BONE VOID FILLER
Applicant
Skeletal Kinetics, LLC
Decision
Substantially Equivalent
Date received
2005-05-03
Decision date
2005-06-03
Days to decision
31 days
Clearance type
Special
Product code
MQV
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Cupertino, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The pr recall (Z-2180-2020)Osteomed, LLC2020-05-29
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The pr recall (Z-2181-2020)Osteomed, LLC2020-05-29
OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The pr recall (Z-2182-2020)Osteomed, LLC2020-05-29
OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The prod recall (Z-2183-2020)Osteomed, LLC2020-05-29
OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The pro recall (Z-2184-2020)Osteomed, LLC2020-05-29
InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bo recall (Z-2209-2015)Skeletal Kinetics, Llc2015-07-24