ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT

Spinal Vertebral Body Replacement Device

ORTHOVITA, INC.

The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Endoskeleton Ta Vertebral Body Replacement.

Pre-market Notification Details

• Device ID: K032812
• 510k Number: K032812
• Device Name: ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355
• Contact: David J Mcilhenny
• Correspondent: David J Mcilhenny; ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-09
• Decision Date: 2003-12-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M682210701180	K032812	000
M68221070120N0	K032812	000
M68221070218N0	K032812	000
M68221070220N0	K032812	000
M68221070318N0	K032812	000
M68221070320N0	K032812	000
00191375018841	K032812	000
00191375028956	K032812	000
00191375052418	K032812	000
00191375030263	K032812	000
00191375030270	K032812	000
00191375030287	K032812	000
00191375035947	K032812	000
M68221070118N0	K032812	000
00191375000099	K032812	000
M682210701200	K032812	000
M682210702180	K032812	000
M682210702200	K032812	000
M682210703180	K032812	000
M682210703200	K032812	000
M682215691180	K032812	000
M682215691200	K032812	000
M682215692180	K032812	000
M682215692200	K032812	000
00191375000068	K032812	000
00191375000075	K032812	000
00191375000082	K032812	000
00191375035954	K032812	000
00191375035961	K032812	000
00191375000037	K032812	000
00191375000044	K032812	000
00191375000051	K032812	000
00191375000105	K032812	000
00191375000112	K032812	000
00191375000129	K032812	000
00191375000136	K032812	000
00191375011989	K032812	000
00191375011996	K032812	000
00191375012009	K032812	000
00191375012016	K032812	000
00191375012023	K032812	000
00191375000020	K032812	000
00191375000013	K032812	000
00191375035978	K032812	000
00191375035985	K032812	000
00191375035992	K032812	000
00191375036005	K032812	000
00191375036012	K032812	000
00191375000143	K032812	000
00191375018858	K032812	000
00191375018865	K032812	000
00191375018872	K032812	000
00191375018889	K032812	000
00191375018896	K032812	000
00191375000006	K032812	000
00191375012030	K032812	000