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510(k) K102488

APEX SPINE SYSTEM W/ COCR RODS by Spinecraft, LLC — Product Code MNH

K102488 is an FDA 510(k) premarket notification submitted by Spinecraft, LLC for the device "APEX SPINE SYSTEM W/ COCR RODS". The FDA issued a decision of Substantially Equivalent on December 10, 2010. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Spinecraft, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2010
Date Received
August 31, 2010
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 Spinecraft, LLC

  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K223301 — ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments (July 20, 2023)
  • K223273 — ASTRA Spine System (December 22, 2022)
  • K211935 — ORIO-Ti Intervertebral Body Fusion Cage System (September 30, 2021)
  • K211323 — ASTRA Spine System (June 3, 2021)
  • K181350 — ASTRA-OCT Spine System (July 6, 2018)
  • K143683 — APEX-DL Spine System (May 22, 2015)
  • K150417 — ASTRA SPINE SYSTEM (May 19, 2015)
  • K131521 — VELOX ANTERIOR CERVICAL PLATE SYSTEM (December 24, 2013)

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