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FDA 510(k)

FLOWER BONE SCREW SET

K-Number: K132248 · 2013-10-30

ApplicantFlower Orthopedics Corporation
Decision Date2013-10-30
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 2013-10-30 under 510(k) number K132248. 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 2013-10-30. The listed applicant is Flower Orthopedics Corporation. The 510(k) number is K132248.

When did FLOWER BONE SCREW SET receive FDA 510(k) clearance?

FLOWER BONE SCREW SET received FDA 510(k) clearance on 2013-10-30, under 510(k) number K132248.

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.

Related Clinical Trials

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.

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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 SetK170687Flower Bone Screw SetK133102FLOWER ANKLE PLATING SETK131657FLOWER SMALL AND MEDIUM IMPLANT SETK123562FLOWER SMALL AND MEDIUM BONE IMPLANTS

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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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