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FDA 510(k)

PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD

K-Number: K061564 · 2006-09-01

ApplicantPortland Orthopaedics Pty. , Ltd.
Decision Date2006-09-01
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD 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 2006-09-01 under 510(k) number K061564. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD?

PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2006-09-01. The listed applicant is Portland Orthopaedics Pty. , Ltd.. The 510(k) number is K061564.

When did PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD receive FDA 510(k) clearance?

PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD received FDA 510(k) clearance on 2006-09-01, under 510(k) number K061564.

Who is the listed applicant for PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD?

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 PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD?

The FDA product code for PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD is LZO.

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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: LZO)

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.

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