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510(k) K240838

Spectrum Spine Cervical Cage System by Spectrum Spine, Inc. — Product Code ODP

K240838 is an FDA 510(k) premarket notification submitted by Spectrum Spine, Inc. for the device "Spectrum Spine Cervical Cage System". The FDA issued a decision of Substantially Equivalent on May 30, 2024. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Spectrum Spine, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2024
Date Received
March 27, 2024
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 Spectrum Spine, Inc.

  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
  • K243074 — Spectrum Spine Lumbar Cage System (April 4, 2025)
  • K201024 — Expandable Titanium PLIF/TLIF System (April 29, 2021)
  • K173518 — Spectrum Spine Expandable Cages (SSEC) (March 7, 2019)
  • K132126 — SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM (October 28, 2013)
  • K122822 — SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM (February 7, 2013)

Other clearances for product code ODP

  • 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)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)

FDA data resources