GLOBUS MEDICAL, INC.

Address:2560 General Armistead Ave,AUDUBON,PA,19403,US

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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

Plate, fixation, bone (HRS) (10) Screw, fixation, bone (HWC) (10)

Premarket Exempt

No Yes

Clear

ANTHEM - 00193982017132 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Left, 17 Hole, 363mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017149 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Left, 19 Hole, 395mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017156 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Left, 21 Hole, 427mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017163 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Left, 23 Hole, 458mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017170 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Right, 3 Hole, 137mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017187 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Right, 5 Hole, 169mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017194 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Right, 7 Hole, 202mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017200 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Right, 9 Hole, 234mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017217 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Right, 11 Hole, 267mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017224 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Right, 13 Hole, 299mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

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