FDA 510(k)

PoreStar Patient Specific Implant

K-Number: K171037 · 2017-12-27

Decision Date2017-12-27

Product CodeJOF

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

PoreStar Patient Specific Implant is the device name listed in this FDA 510(k) record. The listed applicant is Anatomics Pty, Ltd.. It received FDA 510(k) clearance on 2017-12-27 under 510(k) 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. The listed applicant is Anatomics Pty, Ltd.. The 510(k) number is K171037.

When did PoreStar Patient Specific Implant receive FDA 510(k) clearance?

PoreStar Patient Specific Implant received FDA 510(k) clearance on 2017-12-27, under 510(k) number K171037.

Who is the listed applicant for PoreStar Patient Specific Implant?

The FDA 510(k) record lists Anatomics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PoreStar Patient Specific Implant?

The FDA product code for PoreStar Patient Specific Implant is JOF.

Other records listing Anatomics Pty, Ltd. as applicant

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.

K200532StarPore

Related Devices (Code: JOF)

K200532StarPoreAnatomics Pty, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.