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First Choice Druj System, Partial Head Implant

by Ascension Orthopedic 510(k)

Active United States

510(k) K112481

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK112481 Date9 Apr 2012ClearedStatusActive

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  • Withdrawn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
KXE
Device Class
Class II
Regulation
21 CFR Part 888.3810
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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