Zyston Strut Open Titanium Spacer System
K-Number: K171495 · 2018-02-12
ApplicantZimmer Biomet Spine, Inc.
Decision Date2018-02-12
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Zyston Strut Open Titanium Spacer System is a medical device manufactured by Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2018-02-12 under approval number K171495. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Zyston Strut Open Titanium Spacer System?
Zyston Strut Open Titanium Spacer System is a medical device that received FDA 510(k) clearance on 2018-02-12. It is manufactured by Zimmer Biomet Spine, Inc.. The 510(k) number is K171495.
When was Zyston Strut Open Titanium Spacer System approved by the FDA?
Zyston Strut Open Titanium Spacer System received FDA 510(k) clearance on 2018-02-12, under approval number K171495.
What company makes Zyston Strut Open Titanium Spacer System?
Zyston Strut Open Titanium Spacer System is manufactured by Zimmer Biomet Spine, Inc..
What is the FDA product code for Zyston Strut Open Titanium Spacer System?
The FDA product code for Zyston Strut Open Titanium Spacer System is MAX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.