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510(k) K042928

MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM by U&I Corp. — Product Code MNH

K042928 is an FDA 510(k) premarket notification submitted by U&I Corp. for the device "MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 17, 2005. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. U&I Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2005
Date Received
October 22, 2004
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 U&I Corp.

  • K140864 — VELOXTM INTERBODY FUSION SYSTEM (July 22, 2014)
  • K140234 — ASPIRON ACP SYSTEM (June 2, 2014)
  • K132926 — VELOFIXTM INTERBODY FUSION SYSTEM (March 5, 2014)
  • K120419 — DYNA LOCKING ANKLE NAIL (May 21, 2012)
  • K112240 — DYNA LOCKING CANNULATED SCREW (January 4, 2012)
  • K102367 — OPTIGEN TOTAL KNEE SYSTEM (December 8, 2010)
  • K093707 — DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820 (June 23, 2010)
  • K092771 — DYNA LOCKING IM NAIL (December 2, 2009)
  • K091725 — PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) (November 9, 2009)
  • K061002 — MAXIMA ANTERIOR CERVICAL PLATE SYSTEM (November 15, 2006)

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