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) (6) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (4)

Premarket Exempt

Clear

Accufuse Cervical System - 00810016801207 Catalog Number : 10-20-01

Device Description : Case - Lid

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016801214 Catalog Number : 10-20-02

Device Description : Case Base Instrument Tray

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016801221 Catalog Number : 10-20-03

Device Description : Case Implant Tray

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016801238 Catalog Number : 10-20-04

Device Description : Cage Implant Caddy with Lid

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016801245 Catalog Number : 10-20-05

Device Description : Plate Implant Caddy with Lid

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016801252 Catalog Number : 10-20-06

Device Description : Fixed Screw Implant Caddy with Lid

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016801269 Catalog Number : 10-20-07

Device Description : Variable Screw Implant Caddy with Lid

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016801290 Catalog Number : C161405

Device Description : Cervical Peek 16mmx14mmx5mm 7° Lordosis

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016801306 Catalog Number : C161406

Device Description : Cervical PEEK 16mmx14mmx6mm 7° Lordosis

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Accufuse Cervical System - 00810016801313 Catalog Number : C161407

Device Description : Cervical PEEK 16mmx14mmx7mm 7° Lordosis

Device Class : 2

Duns Number: 056248579

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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