K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES

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 K-helix Piston And Porp Partial Ossicular Replacement Prostheses.

Pre-market Notification Details

• Device ID: K080070
• 510k Number: K080070
• Device Name: K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
• 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: 2008-01-10
• Decision Date: 2008-04-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00844505005999	K080070	000
00844505005982	K080070	000