VAULT-C INTERVERTEBRAL BODY FUSION DEVICE

Intervertebral Fusion Device With Integrated Fixation, Cervical

SPINAL USA

The following data is part of a premarket notification filed by Spinal Usa with the FDA for Vault-c Intervertebral Body Fusion Device.

Pre-market Notification Details

• Device ID: K132029
• 510k Number: K132029
• Device Name: VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: SPINAL USA 4628 NORTHPARK DRIVE Colorado Springs, CO 80918
• Contact: Meredith May
• Correspondent: Meredith May; SPINAL USA 4628 NORTHPARK DRIVE Colorado Springs, CO 80918
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-01
• Decision Date: 2013-11-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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