ClearanceBrief
510(k) K133930 ยท HRS Plate, Fixation, Bone

FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET

ApplicantFlower Orthopedics Corporation, Horsham PA, US
DecisionSubstantially Equivalent, Mar 27, 2014
ReceivedDec 23, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K133930

DateFirm and productCodeLinked 510(k)
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calca
Terminated
HRSNone listed
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc
Terminated
HRSNone listed
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calca
Terminated
HRSNone listed
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc
Terminated
HRSNone listed
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the cal
Terminated
HRSNone listed
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc
Terminated
HRSNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.