STANSION MATRIX

Spinal Vertebral Body Replacement Device

SPINEWORKS, LLC

The following data is part of a premarket notification filed by Spineworks, Llc with the FDA for Stansion Matrix.

Pre-market Notification Details

• Device ID: K042600
• 510k Number: K042600
• Device Name: STANSION MATRIX
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: SPINEWORKS, LLC 555 13TH STREET N.W. Washington, DC 20004
• Contact: Jonathan Kahan
• Correspondent: Jonathan Kahan; SPINEWORKS, LLC 555 13TH STREET N.W. Washington, DC 20004
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-09-23
• Decision Date: 2005-02-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M711C1214110	K042600	000
M711B0810070	K042600	000
M711B1012070	K042600	000
M711B1012090	K042600	000
M711B1214070	K042600	000
M711B1214090	K042600	000
M711B1214110	K042600	000
M711C0608070	K042600	000
M711C0810070	K042600	000
M711C1012070	K042600	000
M711C1012090	K042600	000
M711C1214070	K042600	000
M711C1214090	K042600	000
M711B0608070	K042600	000