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

Intervertebral fusion device with bone graft, lumbar (MAX) (8) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (2) Intervertebral fusion device with bone graft, thoracic (PHM) (1) Intervertebral fusion device with integrated fixation, lumbar (OVD) (1)

Premarket Exempt

No Yes

Clear

HEDRON - 00193982000158 Catalog Number :

Device Description : Locking Bone Screw, Self-Drilling 5.5mm, 40mm

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : OVD, MAX, PHM

Prescription Use : No

Device Count : 1

SABLE - 00193982003524 Catalog Number :

Device Description : Inserter Sleeve, ML

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

SABLE - 00193982003531 Catalog Number :

Device Description : Threaded Shaft

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

N/A - 00193982003548 Catalog Number :

Device Description : Torque Limiting Handle, 2.0Nm

Device Class : 1

Duns Number: 139105691

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

N/A - 00193982003555 Catalog Number :

Device Description : Torque Limiting Handle, 1.5Nm

Device Class : 1

Duns Number: 139105691

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SABLE - 00193982003562 Catalog Number :

Device Description : Rigid Driver

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

SABLE - 00193982003579 Catalog Number :

Device Description : Driver, 22mm Length

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

SABLE - 00193982003586 Catalog Number :

Device Description : Driver, 26mm Length

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

SABLE - 00193982003593 Catalog Number :

Device Description : Driver, 30mm Length

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

SABLE - 00193982003616 Catalog Number :

Device Description : Inserter Sleeve, CC

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

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