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510(k) K143377

PedFuse Pedicle Screw System by Spinefrontier, Inc. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2015
Date Received
November 25, 2014
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 Spinefrontier, Inc.

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  • K172484 — A-CIFT SoloFuse (May 8, 2018)
  • K151198 — A-CIFT SoloFuse (July 17, 2015)
  • K142504 — SpineFrontier Lumbar Interbody Fusion Device System (May 13, 2015)
  • K150017 — SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System (April 24, 2015)
  • K141333 — ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (November 25, 2014)
  • K142026 — SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (October 20, 2014)
  • K141337 — ARENA-C (September 8, 2014)
  • K133153 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM (May 14, 2014)
  • K131880 — SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM (January 3, 2014)

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)