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510(k) K100373

TYCHE PEDICLE SCREW SYSTEM by Kyung Won Medical Co., Ltd. — Product Code MNH

K100373 is an FDA 510(k) premarket notification submitted by Kyung Won Medical Co., Ltd. for the device "TYCHE PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on June 30, 2010. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Kyung Won Medical Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2010
Date Received
February 12, 2010
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 Kyung Won Medical Co., Ltd.

  • K092194 — POLYBONE DENTAL (June 16, 2010)
  • K082338 — POLYBONE GRANULE & BLOCK (October 16, 2008)
  • K070012 — POLYBONE (December 27, 2007)

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