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Tyche Pedicle Screw System

by Kyung Won Medical Co., Ltd.

510(k) K100373

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100373 Date30 Jun 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tyche Pedicle Screw System is a non-cervical pedicle screw system designed to provide immobilization and stabilization of spinal segments. It is indicated for the treatment of severe spondylolisthesis of the L5-S1 vertebrae in skeletally mature patients as an adjunct to fusion.

This system is intended for attachment to the lumbar and sacral spine from L3 to the sacrum using autogenous bone graft. The implants are designed for removal after the attainment of a solid fusion. This device has received FDA 510(k) clearance.

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