OBELISC VERTEBRAL BODY REPLACEMENT DEVICE

Spinal Vertebral Body Replacement Device

ULRICH GMBH & CO. KG

The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Obelisc Vertebral Body Replacement Device.

Pre-market Notification Details

• Device ID: K060416
• 510k Number: K060416
• Device Name: OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: ULRICH GMBH & CO. KG 2519 MCMULLEN BOOTH ROAD SUITE 510-295 Clearwater, FL 33759
• Contact: Ian P Gordon
• Correspondent: Ian P Gordon; ULRICH GMBH & CO. KG 2519 MCMULLEN BOOTH ROAD SUITE 510-295 Clearwater, FL 33759
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-02-17
• Decision Date: 2006-12-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04052536198658	K060416	000
04052536005642	K060416	000
04052536005659	K060416	000
04052536005666	K060416	000
04052536005673	K060416	000
04052536005680	K060416	000
04052536005697	K060416	000
04052536005703	K060416	000
04052536005710	K060416	000
04052536005727	K060416	000
04052536013388	K060416	000
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04052536005628	K060416	000
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04052536198672	K060416	000
04052536198689	K060416	000
04052536198696	K060416	000
04052536198702	K060416	000
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04052536198726	K060416	000
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04052536198740	K060416	000
04052536198757	K060416	000
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04052536005567	K060416	000
04052536005574	K060416	000
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04052536005604	K060416	000
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04052536113743	K060416	000
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04052536113804	K060416	000
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04052536013562	K060416	000
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04052536013609	K060416	000
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04052536013623	K060416	000
04052536013630	K060416	000
04052536162963	K060416	000