Z-LINK CERVICAL

Intervertebral Fusion Device With Integrated Fixation, Cervical

ZAVATION, LLC

The following data is part of a premarket notification filed by Zavation, Llc with the FDA for Z-link Cervical.

Pre-market Notification Details

• Device ID: K141005
• 510k Number: K141005
• Device Name: Z-LINK CERVICAL
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: ZAVATION, LLC 400 LIBERTY PARK Flowood, MS 39232
• Contact: John Walker
• Correspondent: John Walker; ZAVATION, LLC 400 LIBERTY PARK Flowood, MS 39232
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-04-18
• Decision Date: 2014-08-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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