ORTHOMEDFLEX LLC

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

Bone Mill (LYS) (3) Impactor (HWA) (2) Reamer (HTO) (2) Broach (HTQ) (1) Guide, Surgical, Instrument (FZX) (1) Osteotome (HWM) (1)

Premarket Exempt

No Yes

Clear

OrthoMedFlex - M7161011020 Catalog Number : 101102

Device Description : Straight Broach Handle - 135 Degrees

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HTQ

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011110 Catalog Number : 101-111

Device Description : Calcar Reamer, 25mm

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LYS

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011120 Catalog Number : 101-112

Device Description : Calcar Mill Reamer

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LYS

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011130 Catalog Number : 101-113

Device Description : Calcar Reamer, 45mm

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LYS

Prescription Use : No

Device Count : 1

OrthoMedFlex, LLC - M7161011200 Catalog Number : 101-120

Device Description : Stepped Entry Reamer

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : No

Device Count : 1

OrthoMedFlex, LLC - M7161011220 Catalog Number : 101-122

Device Description : Tapered Pin Reamer

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011230 Catalog Number : 101-123

Device Description : Osteotomy Guide

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011240 Catalog Number : 101-124

Device Description : Quick Release Box Osteotome

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HWM

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011250 Catalog Number : 101-125

Device Description : Quick Release Head Impactor

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011260 Catalog Number : 101-126

Device Description : Quick Release Stem Impactor

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : No

Device Count : 1

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