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510(k) K180990

TirboLOX-L Lumbar IBFD by Captiva Spine, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2018
Date Received
April 16, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Captiva Spine, Inc.

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

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