Flower Orthopedics Corporation

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
8
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0074-2024Class IICoventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently opeAugust 29, 2023
Z-0448-2022Class IIFlex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the InserterNovember 2, 2021
Z-0034-2022Class IIFlower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201September 3, 2021
Z-0112-2022Class IIFlower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plaSeptember 1, 2021
Z-0111-2022Class IIFlower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any pSeptember 1, 2021
Z-0114-2022Class IIFlower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plateSeptember 1, 2021
Z-0113-2022Class IIFlower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7September 1, 2021
Z-1698-2021Class IIT25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: IntendeApril 15, 2021
Z-2784-2020Class IICalcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be usedJuly 8, 2020
Z-2785-2020Class IICalcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be useJuly 8, 2020
Z-2786-2020Class IICalcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be usJuly 8, 2020
Z-2782-2020Class IICalcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be usedJuly 8, 2020
Z-2783-2020Class IICalcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be useJuly 8, 2020
Z-2787-2020Class IICalcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be useJuly 8, 2020
Z-1113-2017Class IICannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.December 22, 2016
Z-1314-2015Class IIVariable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, VariFebruary 16, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K192949Flower Suture Anchor SetOctober 7, 2020
K170687Flower Bone Screw SetJune 6, 2017
K142306Flower Upper Extremity Plating SetSeptember 15, 2014
K133930FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SETMarch 27, 2014
K133102FLOWER ANKLE PLATING SETNovember 18, 2013
K132248FLOWER BONE SCREW SETOctober 30, 2013
K131657FLOWER SMALL AND MEDIUM IMPLANT SETAugust 22, 2013
K123562FLOWER SMALL AND MEDIUM BONE IMPLANTSMarch 29, 2013