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FDA 510(k)

PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM

K-Number: K024086 · 2003-01-09

ApplicantBiomet Orthopedics, Inc.
Decision Date2003-01-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2003-01-09 under 510(k) number K024086. 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 PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM?

PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-09. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K024086.

When did PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 2003-01-09, under 510(k) number K024086.

Who is the listed applicant for PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM?

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

What is the FDA product code for PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM?

The FDA product code for PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Biomet Orthopedics, Inc. 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.

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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