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FDA 510(k)

Flower Bone Screw Set

K-Number: K170687 · 2017-06-06

ApplicantFlower Orthopedics Corporation
Decision Date2017-06-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Flower Bone Screw Set is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation. It received FDA 510(k) clearance on 2017-06-06 under 510(k) number K170687. 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 Flower Bone Screw Set?

Flower Bone Screw Set is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Flower Orthopedics Corporation. The 510(k) number is K170687.

When did Flower Bone Screw Set receive FDA 510(k) clearance?

Flower Bone Screw Set received FDA 510(k) clearance on 2017-06-06, under 510(k) number K170687.

Who is the listed applicant for Flower Bone Screw Set?

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

What is the FDA product code for Flower Bone Screw Set?

The FDA product code for Flower Bone Screw Set is HWC. This falls under the Cardiovascular category.

Other records listing Flower Orthopedics Corporation as applicant

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.

K192949Flower Suture Anchor Set

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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