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) (7) Screw, fixation, bone (HWC) (7) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (3)

Premarket Exempt

No Yes

Clear

N/A - 00193982016357 Catalog Number :

Device Description : Expandable Distractor, 8x22, 6-12mm

Device Class : 1

Duns Number: 139105691

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

N/A - 00193982016418 Catalog Number :

Device Description : Expandable Distractor, 10x26, 6-12mm

Device Class : 1

Duns Number: 139105691

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

N/A - 00193982016432 Catalog Number :

Device Description : Distractor Handle

Device Class : 1

Duns Number: 139105691

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017064 Catalog Number :

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

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017071 Catalog Number :

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

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017088 Catalog Number :

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

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017095 Catalog Number :

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

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017101 Catalog Number :

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

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017118 Catalog Number :

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

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : No

Device Count : 1

ANTHEM - 00193982017125 Catalog Number :

Device Description : ANTHEM Lateral Narrow Distal Femur Plate, Left, 15 Hole, 331mm, SS

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : No

Device Count : 1

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