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FDA 510(k)

EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD

K-Number: K060918 · 2006-05-26

ApplicantAesculap, Inc.
Decision Date2006-05-26
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2006-05-26 under 510(k) number K060918. 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 EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD?

EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD is a medical device that received FDA 510(k) clearance on 2006-05-26. The listed applicant is Aesculap, Inc.. The 510(k) number is K060918.

When did EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD receive FDA 510(k) clearance?

EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD received FDA 510(k) clearance on 2006-05-26, under 510(k) number K060918.

Who is the listed applicant for EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD?

The FDA product code for EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD is LZO.

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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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