SYNTHES ZERO-P VARIABLE ANGLE (VA)

Intervertebral Fusion Device With Integrated Fixation, Cervical

SYNTHES SPINE CO.LP

The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Zero-p Variable Angle (va).

Pre-market Notification Details

• Device ID: K112068
• 510k Number: K112068
• Device Name: SYNTHES ZERO-P VARIABLE ANGLE (VA)
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380
• Contact: Stacey Bonnell
• Correspondent: Stacey Bonnell; SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-20
• Decision Date: 2011-11-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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