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510(k) K170550

Coveris Cervical Cage System by Camber Spine Technologies — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2017
Date Received
February 24, 2017
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 Camber Spine Technologies

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  • 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)

Other clearances for product code ODP

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  • 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)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)
  • K254105 — Hive™ Standalone Cervical System and Hive™ C Interbody System (February 13, 2026)
  • K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte (January 16, 2026)
  • K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System (January 15, 2026)
  • K252219 — Cervical Interbody and VBR Fusion System (January 14, 2026)
  • K252711 — Advantage-C™ Ti3D Cervical Interbody Fusion Device (January 8, 2026)