SYNTHES USS CONNECTOR

Thoracolumbosacral Pedicle Screw System

SYNTHES SPINE

The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Uss Connector.

Pre-market Notification Details

• Device ID: K120571
• 510k Number: K120571
• Device Name: SYNTHES USS CONNECTOR
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester, PA 19380
• Contact: Hemal Mehta
• Correspondent: Hemal Mehta; SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester, PA 19380
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-02-27
• Decision Date: 2012-05-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H981046323170	K120571	000
H981046323150	K120571	000
H981046323120	K120571	000