ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

ALPHATEC/NEXMED

The following data is part of a premarket notification filed by Alphatec/nexmed with the FDA for Zodiac Polyaxial Spinal Fixation System.

Pre-market Notification Details

• Device ID: K042673
• 510k Number: K042673
• Device Name: ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad, CA 92009
• Contact: Ellen A Yarnall
• Correspondent: Ellen A Yarnall; ALPHATEC/NEXMED 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-09-29
• Decision Date: 2004-10-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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