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FDA 510(k)

OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM

K-Number: K113123 · 2012-01-12

ApplicantThe Orthopaedic Implant Company
Decision Date2012-01-12
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Orthopaedic Implant Company. It received FDA 510(k) clearance on 2012-01-12 under 510(k) number K113123. 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 OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM?

OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-12. The listed applicant is The Orthopaedic Implant Company. The 510(k) number is K113123.

When did OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM receive FDA 510(k) clearance?

OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM received FDA 510(k) clearance on 2012-01-12, under 510(k) number K113123.

Who is the listed applicant for OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM?

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

What is the FDA product code for OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM?

The FDA product code for OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM is KTT.

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Other records listing The Orthopaedic Implant Company as applicant

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Related Devices (Code: 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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