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FDA 510(k)

ROI FUSION RODS & PLATES

K-Number: K051309 · 2005-07-11

ApplicantReiley Orthopaedics, Inc.
Decision Date2005-07-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROI FUSION RODS & PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Reiley Orthopaedics, Inc.. It received FDA 510(k) clearance on 2005-07-11 under 510(k) number K051309. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROI FUSION RODS & PLATES?

ROI FUSION RODS & PLATES is a medical device that received FDA 510(k) clearance on 2005-07-11. The listed applicant is Reiley Orthopaedics, Inc.. The 510(k) number is K051309.

When did ROI FUSION RODS & PLATES receive FDA 510(k) clearance?

ROI FUSION RODS & PLATES received FDA 510(k) clearance on 2005-07-11, under 510(k) number K051309.

Who is the listed applicant for ROI FUSION RODS & PLATES?

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

What is the FDA product code for ROI FUSION RODS & PLATES?

The FDA product code for ROI FUSION RODS & PLATES is HWC. This falls under the Cardiovascular category.

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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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