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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker Spine. It received FDA 510(k) clearance on 2016-07-15 under 510(k) 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. The listed applicant is Stryker Spine. The 510(k) number is K161407.
When did Ascential IBD PEEKc Spacer receive FDA 510(k) clearance?
Ascential IBD PEEKc Spacer received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161407.
Who is the listed applicant for Ascential IBD PEEKc Spacer?
The FDA 510(k) record lists Stryker Spine as the applicant. This does not by itself establish the device manufacturer.
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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Related Devices (Code: ODP)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.