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FDA 510(k)

PORTLAND COBALT CHROME FEMORAL HEAD

K-Number: K063278 · 2007-01-12

ApplicantPortland Orthopaedics Limited
Decision Date2007-01-12
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PORTLAND COBALT CHROME FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Portland Orthopaedics Limited. It received FDA 510(k) clearance on 2007-01-12 under 510(k) number K063278. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTLAND COBALT CHROME FEMORAL HEAD?

PORTLAND COBALT CHROME FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is Portland Orthopaedics Limited. The 510(k) number is K063278.

When did PORTLAND COBALT CHROME FEMORAL HEAD receive FDA 510(k) clearance?

PORTLAND COBALT CHROME FEMORAL HEAD received FDA 510(k) clearance on 2007-01-12, under 510(k) number K063278.

Who is the listed applicant for PORTLAND COBALT CHROME FEMORAL HEAD?

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

What is the FDA product code for PORTLAND COBALT CHROME FEMORAL HEAD?

The FDA product code for PORTLAND COBALT CHROME FEMORAL HEAD is JDI.

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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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