GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL 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 Grace Medical Adjustable And Fixed Length Partial & Total Ossicular Replacement Prostheses.

Pre-market Notification Details

• Device ID: K061853
• 510k Number: K061853
• Device Name: GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL 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: 2006-06-30
• Decision Date: 2006-08-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00844505005227	K061853	000
00844505005371	K061853	000
00844505005388	K061853	000
00844505005395	K061853	000
00844505005401	K061853	000
00844505005418	K061853	000
00844505005425	K061853	000
00844505005432	K061853	000
00844505005449	K061853	000
00844505005456	K061853	000
00844505005463	K061853	000
00844505005470	K061853	000
00844505005364	K061853	000
00844505005357	K061853	000
00844505005340	K061853	000
00844505005234	K061853	000
00844505005241	K061853	000
00844505005258	K061853	000
00844505005265	K061853	000
00844505005272	K061853	000
00844505005289	K061853	000
00844505005296	K061853	000
00844505005302	K061853	000
00844505005319	K061853	000
00844505005326	K061853	000
00844505005333	K061853	000
00844505005487	K061853	000
00844505005494	K061853	000
00844505005500	K061853	000
00844505005654	K061853	000
00844505005661	K061853	000
00844505005678	K061853	000
00844505005685	K061853	000
00844505005692	K061853	000
00844505005708	K061853	000
00844505005715	K061853	000
00844505005722	K061853	000
00844505005739	K061853	000
00844505005746	K061853	000
00844505005753	K061853	000
00844505005647	K061853	000
00844505005630	K061853	000
00844505005623	K061853	000
00844505005517	K061853	000
00844505005524	K061853	000
00844505005531	K061853	000
00844505005548	K061853	000
00844505005555	K061853	000
00844505005562	K061853	000
00844505005579	K061853	000
00844505005586	K061853	000
00844505005593	K061853	000
00844505005609	K061853	000
00844505005616	K061853	000
00844505005760	K061853	000
00844505005210	K061853	000
00844505013901	K061853	000
00844505002127	K061853	000
00844505002141	K061853	000
00844505002158	K061853	000
00844505002165	K061853	000
00844505002172	K061853	000
00844505002189	K061853	000
00844505002196	K061853	000
00844505002202	K061853	000
00844505002219	K061853	000
00844505002233	K061853	000
00844505002240	K061853	000
00844505002110	K061853	000
00844505002103	K061853	000
00844505002097	K061853	000
00844505013765	K061853	000
00844505013772	K061853	000
00844505012744	K061853	000
00844505012300	K061853	000
00844505011921	K061853	000
00844505012751	K061853	000
00844505012584	K061853	000
00844505002059	K061853	000
00844505002066	K061853	000
00844505002073	K061853	000
00844505002080	K061853	000
00844505002257	K061853	000
00844505002264	K061853	000
00844505002271	K061853	000
00844505005098	K061853	000
00844505005104	K061853	000
00844505005111	K061853	000
00844505005128	K061853	000
00844505005135	K061853	000
00844505005142	K061853	000
00844505005159	K061853	000
00844505005166	K061853	000
00844505005173	K061853	000
00844505005180	K061853	000
00844505005197	K061853	000
00844505005081	K061853	000
00844505005074	K061853	000
00844505005067	K061853	000
00844505002288	K061853	000
00844505002318	K061853	000
00844505002325	K061853	000
00844505002332	K061853	000
00844505002349	K061853	000
00844505002356	K061853	000
00844505002363	K061853	000
00844505002370	K061853	000
00844505005036	K061853	000
00844505005043	K061853	000
00844505005050	K061853	000
00844505005203	K061853	000
00844505008716	K061853	000
00844505009102	K061853	000
00844505009119	K061853	000
00844505009126	K061853	000
00844505009133	K061853	000
00844505009157	K061853	000
00844505009164	K061853	000
00844505009171	K061853	000
00844505009188	K061853	000
00844505009195	K061853	000
00844505009393	K061853	000
00844505009409	K061853	000
00844505009096	K061853	000
00844505009089	K061853	000
00844505009072	K061853	000
00844505008723	K061853	000
00844505008730	K061853	000
00844505008747	K061853	000
00844505008754	K061853	000
00844505008761	K061853	000
00844505008778	K061853	000
00844505008785	K061853	000
00844505008792	K061853	000
00844505008808	K061853	000
00844505009058	K061853	000
00844505009065	K061853	000
00844505009416	K061853	000
00844505009423	K061853	000
00844505009430	K061853	000
00844505011099	K061853	000
00844505011150	K061853	000
00844505011167	K061853	000
00844505011235	K061853	000
00844505011242	K061853	000
00844505011259	K061853	000
00844505011266	K061853	000
00844505011273	K061853	000
00844505011280	K061853	000
00844505011563	K061853	000
00844505011754	K061853	000
00844505011082	K061853	000
00844505010894	K061853	000
00844505010887	K061853	000
00844505009447	K061853	000
00844505009454	K061853	000
00844505009461	K061853	000
00844505009843	K061853	000
00844505010177	K061853	000
00844505010337	K061853	000
00844505010344	K061853	000
00844505010351	K061853	000
00844505010368	K061853	000
00844505010375	K061853	000
00844505010382	K061853	000
00844505011761	K061853	000
00844505008709	K061853	000
00844505005777	K061853	000
00844505006026	K061853	000
00844505006132	K061853	000
00844505006149	K061853	000
00844505006156	K061853	000
00844505006163	K061853	000
00844505006422	K061853	000
00844505006774	K061853	000
00844505006781	K061853	000
00844505006798	K061853	000
00844505006897	K061853	000
00844505006903	K061853	000
00844505006019	K061853	000
00844505005975	K061853	000
00844505005913	K061853	000
00844505005784	K061853	000
00844505005791	K061853	000
00844505005807	K061853	000
00844505005814	K061853	000
00844505005821	K061853	000
00844505005838	K061853	000
00844505005845	K061853	000
00844505005852	K061853	000
00844505005869	K061853	000
00844505005876	K061853	000
00844505005883	K061853	000
00844505006910	K061853	000
00844505006927	K061853	000
00844505006934	K061853	000
00844505008082	K061853	000
00844505008099	K061853	000
00844505008150	K061853	000
00844505008600	K061853	000
00844505008624	K061853	000
00844505008631	K061853	000
00844505008648	K061853	000
00844505008655	K061853	000
00844505008662	K061853	000
00844505008679	K061853	000
00844505008686	K061853	000
00844505008051	K061853	000
00844505007610	K061853	000
00844505007603	K061853	000
00844505006958	K061853	000
00844505006965	K061853	000
00844505006972	K061853	000
00844505006989	K061853	000
00844505007047	K061853	000
00844505007054	K061853	000
00844505007061	K061853	000
00844505007078	K061853	000
00844505007191	K061853	000
00844505007573	K061853	000
00844505007597	K061853	000
00844505008693	K061853	000