RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Cervical

RHAUSLER, INC.

The following data is part of a premarket notification filed by Rhausler, Inc. with the FDA for Rhausler Plage Anterior Cervical Fusion System.

Pre-market Notification Details

• Device ID: K111272
• 510k Number: K111272
• Device Name: RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: RHAUSLER, INC. P.O. BOX 745039 Arvada, CO 80006
• Contact: Barbara Debiase
• Correspondent: Barbara Debiase; RHAUSLER, INC. P.O. BOX 745039 Arvada, CO 80006
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-05-04
• Decision Date: 2011-11-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08500591410834	K111272	000
08500591410650	K111272	000
08500591410636	K111272	000
08500591410612	K111272	000
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08500591410735	K111272	000
08500591410728	K111272	000
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08500591410629	K111272	000
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08500591410964	K111272	000
08500591411008	K111272	000
08500591420031	K111272	000
08500591420376	K111272	000
08500591420345	K111272	000
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08500591420307	K111272	000
08500591420284	K111272	000
08500591420239	K111272	000
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08500591420406	K111272	000
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08500591420512	K111272	000
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08500591420482	K111272	000
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08500591410872	K111272	000
08500591420017	K111272	000
08500591420024	K111272	000
08500591420048	K111272	000
08500591420161	K111272	000
08500591420154	K111272	000
08500591420130	K111272	000
08500591420123	K111272	000
08500591420116	K111272	000
08500591420109	K111272	000
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08500591420055	K111272	000
08500591410858	K111272	000