Omni Life Science, Inc.

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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

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED (LPH) (5) Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented (KWY) (5)

Premarket Exempt

Clear

OMNI Hip - 00841690100355 Catalog Number : 302800

Device Description : Femoral CoCr Head 28 mm +0mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

OMNI Hip - 00841690100362 Catalog Number : 302807

Device Description : Femoral CoCr Head 28 mm +7.0mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

OMNI Hip - 00841690100379 Catalog Number : 302810

Device Description : Femoral CoCr Head 28mm +10.5mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

OMNI Hip - 00841690100386 Catalog Number : 302835

Device Description : Femoral CoCr Head 28 mm +3.5mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

OMNI Hip - 00841690100393 Catalog Number : 302899

Device Description : Femoral CoCr Head 28 mm -3.5mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100409 Catalog Number : 410346

Device Description : Acetabular Shell, 46mm, 3 hole, flared, A Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100416 Catalog Number : 410348

Device Description : Acetabular Shell, 48mm, 3 hole, flared, A Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100423 Catalog Number : 410350

Device Description : Acetabular Shell, 50mm, 3 hole, flared, B Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100430 Catalog Number : 410352

Device Description : Acetabular Shell, 52mm, 3 hole, flared, C Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100447 Catalog Number : 410354

Device Description : Acetabular Shell, 54mm, 3 hole, flared, C Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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