NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE

Prosthesis, Partial Ossicular Replacement

Grace Medical, Inc.

The following data is part of a premarket notification filed by Grace Medical, Inc. with the FDA for Nitinol Locking Incudo-stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp And Footplate Shoe.

Pre-market Notification Details

• Device ID: K063374
• 510k Number: K063374
• Device Name: NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
• Classification: Prosthesis, Partial Ossicular Replacement
• Applicant: Grace Medical, Inc. 8500 WOLF LAKE DR., STE. 110 Memphis, TN 38133
• Contact: Jeff Cobb
• Correspondent: Jeff Cobb; Grace Medical, Inc. 8500 WOLF LAKE DR., STE. 110 Memphis, TN 38133
• Product Code: ETB
• CFR Regulation Number: 874.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-08
• Decision Date: 2006-12-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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