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) (10)

Premarket Exempt

No Yes

Clear

OrthoMedFlex - M7161011280 Catalog Number : 101-128

Device Description : Kratos Trial Neck, Standard

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M7161011290 Catalog Number : 101-129

Device Description : Kratos Trial Neck, high Offset (Lateralized)

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex, LLC - M7161011300 Catalog Number : 101-130

Device Description : Kratos Trial Neck, Coxa Vara

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M71610113128L0 Catalog Number : 101-131-28L

Device Description : Trial Femoral Head, 28mm, L (+3.5 mm)

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M71610113128M0 Catalog Number : 101-131-28M

Device Description : Trial Femoral Head, 28mm, M (0.0 mm)

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M71610113128S0 Catalog Number : 101-131-28S

Device Description : Trial Femoral Head, 28mm, S (-3.5 mm)

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M71610113132L0 Catalog Number : 101-131-32L

Device Description : Trial Femoral Head, 32mm, L (+4.0 mm)

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M71610113132M0 Catalog Number : 101-131-32M

Device Description : Trial Femoral Head, 32mm, M (0.0 mm)

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M71610113132S0 Catalog Number : 101-131-32S

Device Description : Trial Femoral Head, 32mm, S (-4.0 mm)

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

OrthoMedFlex - M71610113132XL0 Catalog Number : 101-131-32XL

Device Description : Trial Femoral Head, 32mm, XL (+7.0 mm)

Device Class : 1

Duns Number: 034442726

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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