ATLAS SPINE PEDICLE SCREW SYSTEM

Thoracolumbosacral Pedicle Screw System

ATLAS SPINE INC.

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

Pre-market Notification Details

• Device ID: K110842
• 510k Number: K110842
• Device Name: ATLAS SPINE PEDICLE SCREW SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter, FL 33458
• Contact: Jeannette G Dailey
• Correspondent: Jeannette G Dailey; ATLAS SPINE INC. 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-25
• Decision Date: 2011-07-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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