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510(k) K193153

SPIRA-C Integrated Fixation System by Camber Spine Technologies — Product Code OVE

K193153 is an FDA 510(k) premarket notification submitted by Camber Spine Technologies for the device "SPIRA-C Integrated Fixation System". The FDA issued a decision of Substantially Equivalent on April 24, 2020. The device falls under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical), a Class II device regulated under 21 CFR 888.3080. Camber Spine Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2020
Date Received
November 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Integrated Fixation, 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 with or without supplemental fixation.

Other clearances by Camber Spine Technologies

  • K234077 — SPIRA® Anterior Lumbar Spacers (July 12, 2024)
  • K232256 — Alcantara Thoracolumbar Plate System (April 16, 2024)
  • K233972 — Camber Sacroiliac (SI) Fixation System (February 27, 2024)
  • K230942 — SPIRA® Posterior Lumbar Spacers (July 11, 2023)
  • K221324 — ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) (March 30, 2023)
  • K223837 — SPIRA®-C Integrated Fixation System (March 22, 2023)
  • K203503 — Camber Sacroiliac (SI) Fixation System (September 2, 2022)
  • K220038 — Camber Spine Navigation System (April 29, 2022)
  • K210595 — SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers (June 15, 2021)
  • K191584 — FORTICO Anterior Cervical Fixation System (October 22, 2019)

Other clearances for product code OVE

  • K261279 — DeltaNEC Interbody System (June 22, 2026)
  • K252982 — CONDUIT™ ZERO-P™ VA Secured Spacer System (June 18, 2026)
  • K260036 — NeckTune™ 3D SA Cervical Cage (June 15, 2026)
  • K260660 — SABER-C System (April 27, 2026)
  • K253213 — SAGI Cervical Cage System (April 20, 2026)
  • K252774 — Uni-C Cervical Cage System (April 15, 2026)
  • K260038 — E3D™-C Interbody System (February 4, 2026)
  • K253876 — HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (December 22, 2025)
  • K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
  • K250076 — Endeavor™ Stand-Alone Cervical IBF System (September 25, 2025)

FDA data resources