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

BIT, DRILL (HTW) (7) ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES (HSB) (2) Orthopedic manual surgical instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

K-Wires, 1.1mm x 22, Flex-Thread™ - 00840118118354 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

K-Wires, 1.1mm x 22, Flex-Thread™ - 00840118118361 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

Removal Tool, 3.5mm - 00840118118378 Catalog Number :

Device Description : Orthopaedic implant reamer

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cannulated Drill Bit, 1.7mm - 00840118118385 Catalog Number :

Device Description : Cannulated surgical drill bit, single-use, sterile

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Cannulated Drill Bit, 2.0mm - 00840118118392 Catalog Number :

Device Description : Cannulated surgical drill bit, single-use, sterile

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Cannulated Drill Bit, 2.4mm - 00840118118408 Catalog Number :

Device Description : Cannulated surgical drill bit, single-use, sterile

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Cannulated Drill Bit, 2.6mm - 00840118118415 Catalog Number :

Device Description : Cannulated surgical drill bit, single-use, sterile

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Cannulated Drill Bit, 3.0mm - 00840118118422 Catalog Number :

Device Description : Cannulated surgical drill bit, single-use, sterile

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Cannulated Drill Bit, 3.5mm - 00840118118439 Catalog Number :

Device Description : Cannulated surgical drill bit, single-use, sterile

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Cannulated Drill Bit, 4.0mm - 00840118118446 Catalog Number :

Device Description : Cannulated surgical drill bit, single-use, sterile

Device Class : 1

Duns Number: 078790947

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

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