DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

SPINEART

The following data is part of a premarket notification filed by Spineart with the FDA for Dynamik Intervertebral Body Fusion Device.

Pre-market Notification Details

• Device ID: K081888
• 510k Number: K081888
• Device Name: DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215
• Contact: Franck Pennesi
• Correspondent: Franck Pennesi; SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-07-02
• Decision Date: 2009-02-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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