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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 the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation Dba Conventus Flower Ortho. It received FDA 510(k) clearance on 2024-11-22 under 510(k) 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. The listed applicant is Flower Orthopedics Corporation Dba Conventus Flower Ortho. The 510(k) number is K233567.

When did OsteoCoil™ Nitinol Compression System (Multiple Component PNs) receive FDA 510(k) clearance?

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

Who is the listed applicant for OsteoCoil™ Nitinol Compression System (Multiple Component PNs)?

The FDA 510(k) record lists Flower Orthopedics Corporation Dba Conventus Flower Ortho as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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