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510(k) K151116

CapLOX II/TowerLOX Pedicle Screw System by Captiva Spine — Product Code MNH

K151116 is an FDA 510(k) premarket notification submitted by Captiva Spine for the device "CapLOX II/TowerLOX Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on June 26, 2015. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Captiva Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2015
Date Received
April 27, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Captiva Spine

  • K193270 — CapLOX II®/TowerLOX® MIS Pedicle Screw System (January 31, 2020)
  • 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)
  • 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 MNH

  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (November 3, 2016)
  • K162143 — FixxSure® X-Link (September 23, 2016)
  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)

FDA data resources