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510(k) K181229

TirboLOX-C Cervical IBFD by Captiva Spine, Inc. — Product Code ODP

K181229 is an FDA 510(k) premarket notification submitted by Captiva Spine, Inc. for the device "TirboLOX-C Cervical IBFD". The FDA issued a decision of Substantially Equivalent on September 19, 2018. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Captiva Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2018
Date Received
May 9, 2018
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 Captiva Spine, Inc.

  • K193270 — CapLOX II®/TowerLOX® MIS Pedicle Screw System (January 31, 2020)
  • K180990 — TirboLOX-L Lumbar IBFD (August 13, 2018)
  • K180475 — CapLOX II® / TowerLOX® MIS Pedicle Screw System (March 19, 2018)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K151116 — CapLOX II/TowerLOX Pedicle Screw System (June 26, 2015)
  • K141332 — Captiva Spine SmartLOX Cervical Plate System (June 11, 2015)
  • K142586 — Captiva Spine FuselOX Cervical IBF System (May 28, 2015)
  • K131538 — CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM (August 8, 2013)
  • K122956 — FUSELOX LUMBAR INTERBODY FUSION DEVICE (October 25, 2012)
  • K122332 — TOWERLOX PEDICLE SCREW SYSTEM (October 16, 2012)

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