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510(k) K234077

SPIRA® Anterior Lumbar Spacers by Camber Spine Technologies — Product Code MAX

K234077 is an FDA 510(k) premarket notification submitted by Camber Spine Technologies for the device "SPIRA® Anterior Lumbar Spacers". The FDA issued a decision of Substantially Equivalent on July 12, 2024. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), 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
July 12, 2024
Date Received
December 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

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

Other clearances by Camber Spine Technologies

  • 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)
  • K193153 — SPIRA-C Integrated Fixation System (April 24, 2020)
  • K191584 — FORTICO Anterior Cervical Fixation System (October 22, 2019)

Other clearances for product code MAX

  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)
  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K253583 — LUX Expandable Lumbar Interbody System (February 23, 2026)
  • K250773 — Luna® Ti Interbody Fusion System (February 4, 2026)

FDA data resources