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510(k) K141333

ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE by Spinefrontier, Inc. — Product Code ODP

K141333 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE". The FDA issued a decision of Substantially Equivalent on November 25, 2014. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Spinefrontier, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2014
Date Received
May 21, 2014
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

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

Other clearances by Spinefrontier, Inc.

  • K193106 — SpineFrontier Lumbar Interbody Fusion Device System (June 19, 2020)
  • K172484 — A-CIFT SoloFuse (May 8, 2018)
  • K151198 — A-CIFT SoloFuse (July 17, 2015)
  • K142504 — SpineFrontier Lumbar Interbody Fusion Device System (May 13, 2015)
  • K150017 — SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System (April 24, 2015)
  • K143377 — PedFuse Pedicle Screw System (February 12, 2015)
  • K142026 — SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (October 20, 2014)
  • K141337 — ARENA-C (September 8, 2014)
  • K133153 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM (May 14, 2014)
  • K131880 — SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM (January 3, 2014)

Other clearances for product code ODP

  • K253041 — 3d Cage Cervical (July 23, 2026)
  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)

FDA data resources