Precise Ha Lite Total 720-675

• FDA 510(k) K061853 decided 18 Aug 2006 Active
• FDA GUDID UDI-DI 00844505005142 listed 18 Feb 2016 Listed

1. 18 Aug 2006 Cleared FDA 510(k) K061853
2. 18 Feb 2016 Listed FDA GUDID 00844505005142

Trade name

Precise Ha Lite Total

Generic name

Ossicular prosthesis, total

Model / reference

720-675

Primary DI / UDI-DI

00844505005142

510(k) Number

K061853 ↗

FDA product code

ETA

GMDN term

Ossicular prosthesis, total

Device class

Class II

Regulation number

874.3495

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Ossicular prosthesis, total

Other devices filed under FDA product code ETA (REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL).

• MILLS COLUMELLA PROSTHESIS by Exmoor Plastics, Ltd.
• CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) by Exmoor Plastics, Ltd.
• OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL by Porex Technologies Corp. of Georgia
• H/A TOTAL-REGULAR, H/A TOTAL-OFFSET by River Medical, Inc.
• AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN by Heinz Kurz GmbH Medizintechnik
• BLACK OVAL-TOP TORP/PORP by Smith & Nephew Richards, Inc.
• MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS by Misten Medical Corp.
• BIOGLASS OSSICULAR RECONSTRUCTION PROSTH by American Biomaterials Corp.
• HAPEX MALLEABLE TORP by Smith & Nephew Richards, Inc.
• AUSTIN MODIFIED PARTIAL OSSICULAR RE- 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. →