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

Orthopedic Manual Surgical Instrument (LXH) (3) Gauge, Depth (HTJ) (2) Impactor (HWA) (2) Guide, Surgical, Instrument (FZX) (1) Reamer (HTO) (1) Screwdriver (HXX) (1)

Premarket Exempt

No Yes

Clear

OrthoMedFlex - M7161011510 Catalog Number : 101-151

Device Description : 3.5mm Articulating Screwdriver Shaft

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011590 Catalog Number : 101-159

Device Description : Depth Gauge (Simplified)

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011610 Catalog Number : 101-161

Device Description : Drill Guide

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011620 Catalog Number : 101-162

Device Description : Drill Depth Gauge

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011630 Catalog Number : 101-163

Device Description : Screw Inserter

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M716101164280 Catalog Number : 101-164-28

Device Description : Liner Impactor, Size 28

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : No

Device Count : 1

OrthoMedFlex - M716101164360 Catalog Number : 101-164-36

Device Description : Liner Impactor, Size 36

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011650 Catalog Number : 101-165

Device Description : Alignment Rod

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex, LLC - M7161011660 Catalog Number : 101-166

Device Description : Quick Connect Drill Shaft

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011670 Catalog Number : 101-167

Device Description : Reamer Shaft

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : No

Device Count : 1

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