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FDA 510(k)

TRAUMA INTERNAL FIXATION SYSTEMS

K-Number: K111663 · 2012-03-12

ApplicantDePuy Orthopaedics, Inc.
Decision Date2012-03-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRAUMA INTERNAL FIXATION SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2012-03-12 under 510(k) number K111663. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUMA INTERNAL FIXATION SYSTEMS?

TRAUMA INTERNAL FIXATION SYSTEMS is a medical device that received FDA 510(k) clearance on 2012-03-12. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K111663.

When did TRAUMA INTERNAL FIXATION SYSTEMS receive FDA 510(k) clearance?

TRAUMA INTERNAL FIXATION SYSTEMS received FDA 510(k) clearance on 2012-03-12, under 510(k) number K111663.

Who is the listed applicant for TRAUMA INTERNAL FIXATION SYSTEMS?

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

What is the FDA product code for TRAUMA INTERNAL FIXATION SYSTEMS?

The FDA product code for TRAUMA INTERNAL FIXATION SYSTEMS is HRS.

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Related Devices (Code: HRS)

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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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