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510(k) K082309

CAMBRIA by Seaspine, Inc. — Product Code ODP

K082309 is an FDA 510(k) premarket notification submitted by Seaspine, Inc. for the device "CAMBRIA". The FDA issued a decision of Substantially Equivalent on April 9, 2009. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Seaspine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2009
Date Received
August 13, 2008
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 Seaspine, Inc.

  • K231654 — NorthStar OCT System (August 3, 2023)
  • K150469 — Integra Laminoplasty System (March 23, 2015)
  • K142488 — SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, C (December 18, 2014)
  • K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM (May 1, 2014)
  • K132859 — INTEGRA FACET FIXATION SYSTEM (November 18, 2013)
  • K121924 — INTEGRA INTERSPINOUS PROCESS SYSTEM (September 4, 2013)
  • K130830 — INTEGRA LAMINOPLASTY SYSTEM (May 9, 2013)
  • K122571 — MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM (December 12, 2012)
  • K112206 — CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (January 25, 2012)
  • K111671 — SEASPINE MONOPOLAR PROBE SYSYEM (December 28, 2011)

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