Ascential IBD PEEKc Spacer
K-Number: K161407 · 2016-07-15
ApplicantStryker Spine
Decision Date2016-07-15
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Ascential IBD PEEKc Spacer is a medical device manufactured by Stryker Spine. It received FDA 510(k) clearance on 2016-07-15 under approval number K161407. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ascential IBD PEEKc Spacer?
Ascential IBD PEEKc Spacer is a medical device that received FDA 510(k) clearance on 2016-07-15. It is manufactured by Stryker Spine. The 510(k) number is K161407.
When was Ascential IBD PEEKc Spacer approved by the FDA?
Ascential IBD PEEKc Spacer received FDA 510(k) clearance on 2016-07-15, under approval number K161407.
What company makes Ascential IBD PEEKc Spacer?
Ascential IBD PEEKc Spacer is manufactured by Stryker Spine.
What is the FDA product code for Ascential IBD PEEKc Spacer?
The FDA product code for Ascential IBD PEEKc Spacer is ODP.
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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.