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FDA 510(k)

ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0

K-Number: K072899 · 2008-02-06

ApplicantAesculap Implant Systems, Inc.
Decision Date2008-02-06
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, Inc.. It received FDA 510(k) clearance on 2008-02-06 under 510(k) number K072899. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0?

ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 is a medical device that received FDA 510(k) clearance on 2008-02-06. The listed applicant is Aesculap Implant Systems, Inc.. The 510(k) number is K072899.

When did ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 receive FDA 510(k) clearance?

ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 received FDA 510(k) clearance on 2008-02-06, under 510(k) number K072899.

Who is the listed applicant for ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0?

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

What is the FDA product code for ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0?

The FDA product code for ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 is HAW.

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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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