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Grace Piston 412-500

by Grace Medical, Inc.

Grace Piston 412-500 is a Class II device made by Grace Medical, Inc., cleared under FDA 510(k) K060518 on 28 Jun 2006 and listed in FDA GUDID since 18 Feb 2016 (UDI-DI 00844505006194), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K060518

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00844505006194 UDI-DI Date18 Feb 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK060518 Date28 Jun 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060518 decided 28 Jun 2006 Active
  • FDA GUDID UDI-DI 00844505006194 listed 18 Feb 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2308-2026 FDA Class II initiated 3 Apr 2026

    Due to incorrect functional length on device labeling.

Timeline

3 dated events

  1. Cleared FDA 510(k) K060518
  2. Listed FDA GUDID 00844505006194
  3. Recall initiated FDA recalls Z-2308-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Grace Piston
Generic name
Ossicular prosthesis, partial
Model / reference
412-500
Primary DI / UDI-DI
00844505006194
510(k) Number
FDA product code
ETB
GMDN term
Ossicular prosthesis, partial
Device class
Class II
Regulation number
874.3450
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Ossicular prosthesis, partial

Cleared under the same submission (K060518)

and 8 more cleared under K060518

Similar devices

Other devices filed under FDA product code ETB (PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT).

Other devices from Grace Medical, Inc.

See all devices from Grace Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)