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, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER (JWH) (8) PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED (LPH) (2)

Premarket Exempt

Clear

Cancellous Bone Screw, 6.5mm - 00841690100751 Catalog Number : 456565

Device Description : Cancellous bone screw 6.5mm x 65mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Cancellous Bone Screw, 6.5mm - 00841690100768 Catalog Number : 456570

Device Description : Cancellous bone screw 6.5mm x 70mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

APEX CR Knee - 00841690100805 Catalog Number : KC-1101L

Device Description : CR Femoral Cemented, Size 1 Left

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

APEX CR Knee - 00841690100812 Catalog Number : KC-1101R

Device Description : CR Femoral Cemented, Size 1 Right

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

APEX CR Knee - 00841690100829 Catalog Number : KC-1102L

Device Description : CR Femoral Cemented, Size 2 Left

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

APEX CR Knee - 00841690100836 Catalog Number : KC-1102R

Device Description : CR Femoral Cemented, Size 2 Right

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

APEX CR Knee - 00841690100843 Catalog Number : KC-1103L

Device Description : CR Femoral Cemented, Size 3 Left

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

APEX CR Knee - 00841690100850 Catalog Number : KC-1103R

Device Description : CR Femoral Cemented, Size 3 Right

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

APEX CR Knee - 00841690100867 Catalog Number : KC-1104L

Device Description : CR Femoral Cemented, Size 4 Left

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

APEX CR Knee - 00841690100874 Catalog Number : KC-1104R

Device Description : CR Femoral Cemented, Size 4 Right

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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