FDA 510(k)

StarPore

K-Number: K200532 · 2020-06-02

Decision Date2020-06-02

Product CodeJOF

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

StarPore 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 2020-06-02 under 510(k) number K200532. 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 StarPore?

StarPore is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Anatomics Pty, Ltd.. The 510(k) number is K200532.

When did StarPore receive FDA 510(k) clearance?

StarPore received FDA 510(k) clearance on 2020-06-02, under 510(k) number K200532.

Who is the listed applicant for StarPore?

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 StarPore?

The FDA product code for StarPore 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.

K171037PoreStar Patient Specific Implant

Related Devices (Code: JOF)

K171037PoreStar Patient Specific ImplantAnatomics Pty, Ltd.

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.