ABSOLUTE ADVANTAGE MEDICAL, LLC

Address:1285 Old US Highway 1 S,Southern Pines,NC,28387,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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (9) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (1)

Premarket Exempt

Clear

Accufuse Cervical System - 00810016800903 Catalog Number : 10-10

Device Description : Torque Limiter Handle -13 in.lbs/1.5 N-m

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016800910 Catalog Number : 10-11-07

Device Description : Dual Drill Guide Block-7mm Plate

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016800927 Catalog Number : 10-11-08

Device Description : Dual Drill Guide Block-8mm Plate

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016800934 Catalog Number : 10-11-09

Device Description : Dual Drill Guide Block-9mm Plate

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016800941 Catalog Number : 10-11-10

Device Description : Dual Drill Guide Block-10mm Plate

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016800958 Catalog Number : 10-11-11

Device Description : Dual Drill Guide Block-11mm Plate

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016800965 Catalog Number : 10-11-12

Device Description : Dual Drill Guide Block-12mm Plate

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016800972 Catalog Number : 10-11-13

Device Description : Dual Drill Guide Block-13mm Plate

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016800989 Catalog Number : 10-11-14

Device Description : Dual Drill Guide Block-14mm Plate

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016800996 Catalog Number : 10-12-05

Device Description : Cage Trial 5mm

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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