FLOWER ORTHOPEDICS CORPORATION

Address:100 Witmer Rd Ste 280,Horsham,PA,19044,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

REAMER (HTO) (4) Kit, surgical instrument, disposable (KDD) (1) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1) BIT, DRILL (HTW) (1) ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES (HSB) (1) Screw, fixation, bone (HWC) (1) PASSER, WIRE, ORTHOPEDIC (HXI) (1)

Premarket Exempt

No Yes

Clear

Cannulated Reamer, 4.2mm, AO Quick Connect, Flex-ThreadTM - 00840118117951 Catalog Number :

Device Description : Medullary canal orthopaedic reamer, rigid

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Cannulated Reamer, 4.2mm, AO Quick Connect, Flex-Thread™ - 00840118117968 Catalog Number :

Device Description : Reamer

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Cannulated Reamer, 5.2mm, AO Quick Connect, Flex-Thread™ - 00840118117982 Catalog Number :

Device Description : Reamer

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

3.7/6.3mm Drill Sleeve - 00840118117999 Catalog Number :

Device Description : Drill Bit Sleeve

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

3.2mm Reamer Sleeve, Tissue Protector - 00840118118026 Catalog Number :

Device Description : Reamer Sleeve

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

1.6mm K-Wire Stabilization Sleeve - 00840118118033 Catalog Number :

Device Description : Orthopedic Manual Surgical Instrument

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

End Cap 1mm, T8 - 00840118118064 Catalog Number :

Device Description : Intramedullary fixation rod and accessories

Device Class : 2

Duns Number: 078790947

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Flower E-Kit, Medium Advanced - 00840118118071 Catalog Number :

Device Description : Flower E-Kit, Medium Advanced

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : Yes

Device Count : 1

Fracture Finger - 00840118118088 Catalog Number :

Device Description : Orthopedic Passer Wire

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

Headless Compression Screw 5.0mm x 30mm - 00840118118149 Catalog Number :

Device Description : Orthopaedic bone screw, non-bioabsorbable, sterile

Device Class : 2

Duns Number: 078790947

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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