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FDA 510(k)

EQUATOR PLUS ACETABULAR CUP SYSTEM

K-Number: K051844 · 2005-10-07

ApplicantPortland Orthopaedics Pty. , Ltd.
Decision Date2005-10-07
Product CodeMAY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EQUATOR PLUS ACETABULAR CUP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Portland Orthopaedics Pty. , Ltd.. It received FDA 510(k) clearance on 2005-10-07 under 510(k) number K051844. The device is classified under product code MAY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EQUATOR PLUS ACETABULAR CUP SYSTEM?

EQUATOR PLUS ACETABULAR CUP SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-07. The listed applicant is Portland Orthopaedics Pty. , Ltd.. The 510(k) number is K051844.

When did EQUATOR PLUS ACETABULAR CUP SYSTEM receive FDA 510(k) clearance?

EQUATOR PLUS ACETABULAR CUP SYSTEM received FDA 510(k) clearance on 2005-10-07, under 510(k) number K051844.

Who is the listed applicant for EQUATOR PLUS ACETABULAR CUP SYSTEM?

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

What is the FDA product code for EQUATOR PLUS ACETABULAR CUP SYSTEM?

The FDA product code for EQUATOR PLUS ACETABULAR CUP SYSTEM is MAY.

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Other records listing Portland Orthopaedics 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.

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Related Devices (Code: MAY)

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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.

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