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FDA 510(k)

UNIVERSAL TAPER DELTA FEMORAL HEAD

K-Number: K070885 · 2007-05-16

ApplicantHowmedica Osteonics Corp.
Decision Date2007-05-16
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL TAPER DELTA FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2007-05-16 under 510(k) number K070885. 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 UNIVERSAL TAPER DELTA FEMORAL HEAD?

UNIVERSAL TAPER DELTA FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2007-05-16. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K070885.

When did UNIVERSAL TAPER DELTA FEMORAL HEAD receive FDA 510(k) clearance?

UNIVERSAL TAPER DELTA FEMORAL HEAD received FDA 510(k) clearance on 2007-05-16, under 510(k) number K070885.

Who is the listed applicant for UNIVERSAL TAPER DELTA FEMORAL HEAD?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL TAPER DELTA FEMORAL HEAD?

The FDA product code for UNIVERSAL TAPER DELTA FEMORAL HEAD is LZO.

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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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