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510(k) K232256

Alcantara Thoracolumbar Plate System by Camber Spine Technologies, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2024
Date Received
July 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Camber Spine Technologies, LLC

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  • 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)

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