SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Cervical

SPINAL USA

The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Anterior Cervical Interbody Fusion Device.

Pre-market Notification Details

• Device ID: K083118
• 510k Number: K083118
• Device Name: SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208
• Contact: Jeffrey Johnson
• Correspondent: Jeffrey Johnson; SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-10-22
• Decision Date: 2009-05-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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