Db Titanium Strut 657B

• FDA 510(k) K061853 decided 18 Aug 2006 Active
• FDA GUDID UDI-DI 00844505012584 listed 25 Sep 2019 Listed

1. 18 Aug 2006 Cleared FDA 510(k) K061853
2. 25 Sep 2019 Listed FDA GUDID 00844505012584

Trade name

Db Titanium Strut

Generic name

Ossicular prosthesis, partial

Model / reference

657B

Primary DI / UDI-DI

00844505012584

510(k) Number

K061853 ↗

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

Category: Ossicular prosthesis, partial

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

• SMITH & NEPHEW OFF-CENTERED PORP by Gyrus Ent LLC
• CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 by Heinz Kurz GmbH Medizintechnik
• TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY by Richard'S Medical Equip., Inc.
• SHEA LOCKING BAIL PROSTHESIS by Richard'S Medical Equip., Inc.
• BUCKET PROSTHESIS PORP by Treace Medical, Inc.
• TEF/PLATINUM PISTON by River Medical, Inc.
• PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) by Mednet Locator, Inc.
• Audioprosthesis SPL 03.00.400 by AUDIO TECHNOLOGIES SRL
• WEHRS INCUS AND INCUS-STAPES PROSTHESES by Smith & Nephew Richards, Inc.
• CAUSSE SPONGE BOAT by Treace Medical, Inc.

• Titanium/Fluoroplastic Piston 409-600 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-525 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-550 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-575 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

See all devices from Grace Medical, Inc. →