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510(k) K211501

Advantage-C PEEK Cervical lnterbody Fusion Device by Lntelivation, LLC — Product Code ODP

K211501 is an FDA 510(k) premarket notification submitted by Lntelivation, LLC for the device "Advantage-C PEEK Cervical lnterbody Fusion Device". The FDA issued a decision of Substantially Equivalent on Aug 24, 2021. 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 24, 2021
Date Received
May 14, 2021
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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  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES… (Apr 13, 2026)

FDA data resources