VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES

Spinal Vertebral Body Replacement Device

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Verte-stack Spinal System, Extra Small Sizes.

Pre-market Notification Details

• Device ID: K030736
• 510k Number: K030736
• Device Name: VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Richard Treharne
• Correspondent: Richard Treharne; MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-03-10
• Decision Date: 2003-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000857035	K030736	000
00763000857271	K030736	000
00763000857295	K030736	000
00763000857301	K030736	000
00763000857318	K030736	000
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00763000857103	K030736	000
00763000857110	K030736	000
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00721902913150	K030736	000
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00721902913204	K030736	000