ORTHOMEDFLEX LLC

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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

Impactor (HWA) (2) Bone Mill (LYS) (2) Screwdriver (HXX) (2) Reamer (HTO) (1) Orthopedic Manual Surgical Instrument (LXH) (1) Broach (HTQ) (1) Extractor (HWB) (1)

Premarket Exempt

No Yes

Clear

OrthoMedFlex - M7161011360 Catalog Number : 101-136

Device Description : Slap Hammer

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011370 Catalog Number : 101-137

Device Description : Canal Reamer

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LYS

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011380 Catalog Number : 101-138

Device Description : Trochanteric Reamer

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LYS

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011390 Catalog Number : 101-139

Device Description : Starter Broach

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HTQ

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011410 Catalog Number : 101-141

Device Description : Femoral Head Extractor

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HWB

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011420 Catalog Number : 101-142

Device Description : Thin Reamer Handle

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : No

Device Count : 1

OrthoMedFlex, LLC - M7161011430 Catalog Number : 101-143

Device Description : Q/C Stem Extractor/Impactor

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : No

Device Count : 1

OrthoMedFlex - M716101144010 Catalog Number : 101-144-01

Device Description : Thread Adaptor

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011480 Catalog Number : 101-148

Device Description : 3.5mm Hex Screwdriver Shaft

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011490 Catalog Number : 101-149

Device Description : 3.5mm Flexible Screwdriver Shaft

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : No

Device Count : 1

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