SYNTHES ACIS/VERTEBRAL SPACER CR

Intervertebral Fusion Device With Bone Graft, Cervical

SYNTHES (USA) LLC

The following data is part of a premarket notification filed by Synthes (usa) Llc with the FDA for Synthes Acis/vertebral Spacer Cr.

Pre-market Notification Details

• Device ID: K120275
• 510k Number: K120275
• Device Name: SYNTHES ACIS/VERTEBRAL SPACER CR
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: SYNTHES (USA) LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380
• Contact: Heather Guerin
• Correspondent: Heather Guerin; SYNTHES (USA) LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-30
• Decision Date: 2012-05-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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