ATLAS SPINE PEDICLE SCREW SYSTEM

Thoracolumbosacral Pedicle Screw System

ATLAS SPINE LLC

The following data is part of a premarket notification filed by Atlas Spine Llc with the FDA for Atlas Spine Pedicle Screw System.

Pre-market Notification Details

• Device ID: K072426
• 510k Number: K072426
• Device Name: ATLAS SPINE PEDICLE SCREW SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: ATLAS SPINE LLC 1555 JUPITER PARK DR., STE. 4 Jupiter, FL 33458
• Contact: Jeanette G Dailey
• Correspondent: Jeanette G Dailey; ATLAS SPINE LLC 1555 JUPITER PARK DR., STE. 4 Jupiter, FL 33458
• Product Code: NKB
• 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: 2007-08-29
• Decision Date: 2007-10-19
• Summary: summary

NIH GUDID Devices

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