FDA 510(k)

OsteoCoil Nitinol Compression System (Multiple Component PNs)

K-Number: K233567 · 2024-11-22

ApplicantFlower Orthopedics Corporation Dba Conventus Flower Ortho

Decision Date2024-11-22

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OsteoCoil Nitinol Compression System (Multiple Component PNs) is a medical device manufactured by Flower Orthopedics Corporation Dba Conventus Flower Ortho. It received FDA 510(k) clearance on 2024-11-22 under approval number K233567. 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 OsteoCoil Nitinol Compression System (Multiple Component PNs)?

OsteoCoil Nitinol Compression System (Multiple Component PNs) is a medical device that received FDA 510(k) clearance on 2024-11-22. It is manufactured by Flower Orthopedics Corporation Dba Conventus Flower Ortho. The 510(k) number is K233567.

When was OsteoCoil Nitinol Compression System (Multiple Component PNs) approved by the FDA?

OsteoCoil Nitinol Compression System (Multiple Component PNs) received FDA 510(k) clearance on 2024-11-22, under approval number K233567.

What company makes OsteoCoil Nitinol Compression System (Multiple Component PNs)?

OsteoCoil Nitinol Compression System (Multiple Component PNs) is manufactured by Flower Orthopedics Corporation Dba Conventus Flower Ortho.

What is the FDA product code for OsteoCoil Nitinol Compression System (Multiple Component PNs)?

The FDA product code for OsteoCoil Nitinol Compression System (Multiple Component PNs) 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.