ICON POLYAXIAL PEDICLE SCREW SYSTEM

Appliance, Fixation, Spinal Interlaminal

ALPHATEC MFG., INC.

The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Icon Polyaxial Pedicle Screw System.

Pre-market Notification Details

• Device ID: K033090
• 510k Number: K033090
• Device Name: ICON POLYAXIAL PEDICLE SCREW SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: ALPHATEC MFG., INC. 6110 CORTE DEL CEDRO Carlsbad, CA 92009
• Contact: Ellen A Hicks
• Correspondent: Ellen A Hicks; ALPHATEC MFG., INC. 6110 CORTE DEL CEDRO Carlsbad, CA 92009
• Product Code: KWP
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-29
• Decision Date: 2004-03-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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