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510(k) K092420

KRD1 PEDICLE SCREW SYSTEM by Spinefrontier, Inc. — Product Code MNI

K092420 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "KRD1 PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on November 19, 2009. The device falls under product code MNI (Orthosis, Spinal Pedicle 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
November 19, 2009
Date Received
August 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle 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 MNI

  • K171497 — Mikron Spinal Fixation System (October 12, 2017)
  • K160731 — LumFix Spinal Fixation Sytem (October 4, 2016)
  • K151458 — Double Medical Universal Spine System (August 22, 2016)
  • K153273 — MySpine Pedicle Screw Placement Guides - LP (June 29, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K160320 — Premier (April 1, 2016)
  • K160003 — Sniper (R) Spine System (February 26, 2016)
  • K152324 — YAHUA Spinal System (February 1, 2016)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)

FDA data resources