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510(k) K123164

SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM by Spinefrontier, Inc. — Product Code MNH

K123164 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on February 15, 2013. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Spinefrontier, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2013
Date Received
October 9, 2012
Clearance Type
Traditional
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.

  • K193106 — SpineFrontier Lumbar Interbody Fusion Device System (June 19, 2020)
  • 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)
  • K143377 — PedFuse Pedicle Screw System (February 12, 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)

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