PoreStar Patient Specific Implant
K-Number: K171037 · 2017-12-27
ApplicantAnatomics Pty, Ltd.
Decision Date2017-12-27
Product CodeJOF
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
PoreStar Patient Specific Implant is a medical device manufactured by Anatomics Pty, Ltd.. It received FDA 510(k) clearance on 2017-12-27 under approval number K171037. The device is classified under product code JOF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PoreStar Patient Specific Implant?
PoreStar Patient Specific Implant is a medical device that received FDA 510(k) clearance on 2017-12-27. It is manufactured by Anatomics Pty, Ltd.. The 510(k) number is K171037.
When was PoreStar Patient Specific Implant approved by the FDA?
PoreStar Patient Specific Implant received FDA 510(k) clearance on 2017-12-27, under approval number K171037.
What company makes PoreStar Patient Specific Implant?
PoreStar Patient Specific Implant is manufactured by Anatomics Pty, Ltd..
What is the FDA product code for PoreStar Patient Specific Implant?
The FDA product code for PoreStar Patient Specific Implant is JOF.
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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.