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510(k) K181471

ACCUFUSE Cervical System by Absolute Advantage Medical, LLC — Product Code ODP

K181471 is an FDA 510(k) premarket notification submitted by Absolute Advantage Medical, LLC for the device "ACCUFUSE Cervical System". The FDA issued a decision of Substantially Equivalent on Aug 29, 2018. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 29, 2018
Date Received
Jun 4, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type
510(k)

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
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  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (Apr 24, 2026)
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  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES… (Apr 13, 2026)

FDA data resources