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Fixion Dynamic Hip Screw System (Fixion Dhs)

by Disco-O-Tech Medical Technologies, Ltd. 510(k)

Active United States

510(k) K031401

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031401 Date6 Aug 2003ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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