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

Premarket Exempt

No Yes

Clear

N/A - 00193982000004 Catalog Number :

Device Description : Point to Lobster Claw Reduction Forceps

Device Class : 1

Duns Number: 139105691

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

N/A - 00193982000028 Catalog Number :

Device Description : Butterfly Fragment Clamp, Steep Curve

Device Class : 1

Duns Number: 139105691

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

HEDRON - 00193982000035 Catalog Number :

Device Description : Locking Bone Screw, 5.5mm, 20mm

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX, OVD, PHM

Prescription Use : No

Device Count : 1

HEDRON - 00193982000042 Catalog Number :

Device Description : Locking Bone Screw, 5.5mm, 25mm

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX, PHM, OVD

Prescription Use : No

Device Count : 1

HEDRON - 00193982000059 Catalog Number :

Device Description : Locking Bone Screw, 5.5mm, 30mm

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : PHM, MAX, OVD

Prescription Use : No

Device Count : 1

HEDRON - 00193982000066 Catalog Number :

Device Description : Locking Bone Screw, 5.5mm, 35mm

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : OVD, MAX, PHM

Prescription Use : No

Device Count : 1

HEDRON - 00193982000073 Catalog Number :

Device Description : Locking Bone Screw, 5.5mm, 40mm

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX, OVD, PHM

Prescription Use : No

Device Count : 1

HEDRON - 00193982000127 Catalog Number :

Device Description : Locking Bone Screw, Self-Drilling 5.5mm, 25mm

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : OVD, MAX, PHM

Prescription Use : No

Device Count : 1

HEDRON - 00193982000134 Catalog Number :

Device Description : Locking Bone Screw, Self-Drilling 5.5mm, 30mm

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX, PHM, OVD

Prescription Use : No

Device Count : 1

HEDRON - 00193982000141 Catalog Number :

Device Description : Locking Bone Screw, Self-Drilling 5.5mm, 35mm

Device Class : 2

Duns Number: 139105691

Premarket Exempt : No

Product Code : MAX, PHM, OVD

Prescription Use : No

Device Count : 1

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