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510(k) K193270

CapLOX II®/TowerLOX® MIS Pedicle Screw System by Captiva Spine, Inc. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2020
Date Received
November 26, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Captiva Spine, Inc.

  • K181229 — TirboLOX-C Cervical IBFD (September 19, 2018)
  • 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 NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)