Frisbee Partial 750-050

• FDA 510(k) K061853 decided 18 Aug 2006 Active
• FDA GUDID UDI-DI 00844505005746 listed 18 Feb 2016 Listed

1. 18 Aug 2006 Cleared FDA 510(k) K061853
2. 18 Feb 2016 Listed FDA GUDID 00844505005746

Trade name

Frisbee Partial

Generic name

Ossicular prosthesis, partial

Model / reference

750-050

Primary DI / UDI-DI

00844505005746

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).

• PARTIAL OSSICULAR REPLACEMENT PROSTHESIS by Anthony D. Prescott
• Kurz K-Piston Titanium Stapedial Prosthesis Model 1006 103-1006 170 by Heinz Kurz GmbH Medizintechnik
• MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS by Misten Medical Corp.
• H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET by River Medical, Inc.
• POLY-WIRE PISTON by Micromed Development Corp.
• AUDIO TECHNOLOGIES S:R.1 by Audio Technologies S.R.L.
• HAPEX MALLEABLE PORP by Smith & Nephew Richards, Inc.
• MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS by Micromedics, Inc.
• XOMED PLATINUM WIRE TEFLON PISTION by Xomed, Inc.
• KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 by Heinz Kurz

• 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. →