DYMAXEON SPINE SYSTEM

Thoracolumbosacral Pedicle Screw System

B2B SPINE PTY LTD

The following data is part of a premarket notification filed by B2b Spine Pty Ltd with the FDA for Dymaxeon Spine System.

Pre-market Notification Details

• Device ID: K121786
• 510k Number: K121786
• Device Name: DYMAXEON SPINE SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: B2B SPINE PTY LTD 1331 H ST NW 12 FL Washington, DC 20005
• Contact: Justin Eggleton
• Correspondent: Justin Eggleton; B2B SPINE PTY LTD 1331 H ST NW 12 FL Washington, DC 20005
• 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: 2012-06-18
• Decision Date: 2012-11-05
• Summary: summary

NIH GUDID Devices

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