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510(k) K031265

SHIRAZ-JAVA SPINAL FIXATION SYSTEM by Spine Next SA — Product Code MNH

K031265 is an FDA 510(k) premarket notification submitted by Spine Next SA for the device "SHIRAZ-JAVA SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 9, 2003. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Spine Next SA has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2003
Date Received
April 21, 2003
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 Spine Next SA

  • K030767 — FIDJI SMALL CEMENT RESTRICTOR (December 22, 2003)
  • K030871 — FIDJI LARGE CEMENT RESTRICTOR (December 22, 2003)

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