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FDA 510(k)

ODRC-DYNAMIC HIP SCREW SYSTEM

K-Number: K103015 · 2011-04-13

ApplicantOrthopaedic Device Research Center
Decision Date2011-04-13
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ODRC-DYNAMIC HIP SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Device Research Center. It received FDA 510(k) clearance on 2011-04-13 under 510(k) number K103015. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODRC-DYNAMIC HIP SCREW SYSTEM?

ODRC-DYNAMIC HIP SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-13. The listed applicant is Orthopaedic Device Research Center. The 510(k) number is K103015.

When did ODRC-DYNAMIC HIP SCREW SYSTEM receive FDA 510(k) clearance?

ODRC-DYNAMIC HIP SCREW SYSTEM received FDA 510(k) clearance on 2011-04-13, under 510(k) number K103015.

Who is the listed applicant for ODRC-DYNAMIC HIP SCREW SYSTEM?

The FDA 510(k) record lists Orthopaedic Device Research Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ODRC-DYNAMIC HIP SCREW SYSTEM?

The FDA product code for ODRC-DYNAMIC HIP SCREW SYSTEM is KTT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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