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) (10) Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (LZO) (2) Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate (MEH) (2)

Premarket Exempt

Clear

OMNI Interface Acetabular System - 00841690100454 Catalog Number : 410356

Device Description : Acetabular Shell, 56mm, 3 hole, flared, D Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100461 Catalog Number : 410358

Device Description : Acetabular Shell, 58mm, 3 hole, flared, D Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100478 Catalog Number : 410360

Device Description : Acetabular Shell, 60mm, 3 hole, flared, E Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100485 Catalog Number : 410362

Device Description : Acetabular Shell, 62mm, 3 hole, flared, E Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100492 Catalog Number : 410364

Device Description : Acetabular Shell, 64mm, 3 hole, flared, E Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100508 Catalog Number : 410366

Device Description : Acetabular Shell, 66mm, 3 hole, flared, E Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100515 Catalog Number : 410368

Device Description : Acetabular Shell, 68mm, 3 hole, flared, F Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100522 Catalog Number : 410370

Device Description : Acetabular Shell, 70mm, 3 hole, flared, F Insert

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100539 Catalog Number : 433728

Device Description : Acetabular Insert, A/28, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH, MEH, LZO

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100546 Catalog Number : 433928

Device Description : Acetabular Insert, B/28, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LZO, LPH, MEH

Prescription Use : Yes

Device Count : 1

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