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, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER (MBH) (5) PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER (JWH) (5)

Premarket Exempt

Clear

APEX Knee System - 00841690134299 Catalog Number : EP-24516

Device Description : PS-R Insert, Size 5 x 16mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : MBH, JWH

Prescription Use : Yes

Device Count : 1

APEX Knee System - 00841690134305 Catalog Number : EP-24518

Device Description : PS-R Insert, Size 5 x 18mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : JWH, MBH

Prescription Use : Yes

Device Count : 1

APEX Knee System - 00841690134312 Catalog Number : EP-24520

Device Description : PS-R Insert, Size 5 x 20mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : MBH, JWH

Prescription Use : Yes

Device Count : 1

APEX Knee System - 00841690134329 Catalog Number : EP-24524

Device Description : PS-R Insert, Size 5 x 24mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : MBH, JWH

Prescription Use : Yes

Device Count : 1

APEX Knee System - 00841690134336 Catalog Number : EP-24528

Device Description : PS-R Insert, Size 5 x 28mm

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : JWH, MBH

Prescription Use : Yes

Device Count : 1

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