ACUITY SURGICAL DEVICES, LLC

Address:8710 N Royal Lane,Irving,TX,75063,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 Integrated Fixation, Lumbar (OVD) (10)

Premarket Exempt

Clear

A Link Z - 00810043480222 Catalog Number :

Device Description : Torque Handle

Device Class : 2

Duns Number: 025855111

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

A Link Z - 00810043480239 Catalog Number :

Device Description : Cover Plate Screwdriver

Device Class : 2

Duns Number: 025855111

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

A Link Z - 00810043480246 Catalog Number :

Device Description : 1/4" Square Slap Hammer

Device Class : 2

Duns Number: 025855111

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

A Link Z - 00810043480291 Catalog Number :

Device Description : Cover Plate Rescue Driver

Device Class : 2

Duns Number: 025855111

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

A Link Z - 00810043480307 Catalog Number :

Device Description : Fixed Handle Mallet

Device Class : 2

Duns Number: 025855111

Premarket Exempt : No

Product Code : OVD

Prescription Use : No

Device Count : 1

A Link Z - 00810043480314 Catalog Number :

Device Description : Cone Guide Straight Screwdriver, Retention Style

Device Class : 2

Duns Number: 025855111

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

A Link Z - 00810043480321 Catalog Number :

Device Description : A Link Z Break Off Coverplate Assembly

Device Class : 2

Duns Number: 025855111

Premarket Exempt : No

Product Code : OVD

Prescription Use : No

Device Count : 1

A Link Z - 00810043480338 Catalog Number :

Device Description : AL Coverplate Assembly

Device Class : 2

Duns Number: 025855111

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

A Link Z - 00810043480352 Catalog Number :

Device Description : A Link Z Ti Unitary Interbody 38x30x13 7°

Device Class : 2

Duns Number: 025855111

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

A Link Z - 00810043480369 Catalog Number :

Device Description : A Link Z Ti Unitary Interbody 38x30x15 7°

Device Class : 2

Duns Number: 025855111

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

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