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FDA 510(k)

OSTEOMED HEADLESS CANNULATED SCREW SYSTEM

K-Number: K063298 · 2007-03-02

ApplicantOsteomed LP
Decision Date2007-03-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOMED HEADLESS CANNULATED SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed LP. It received FDA 510(k) clearance on 2007-03-02 under 510(k) number K063298. 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 OSTEOMED HEADLESS CANNULATED SCREW SYSTEM?

OSTEOMED HEADLESS CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-02. The listed applicant is Osteomed LP. The 510(k) number is K063298.

When did OSTEOMED HEADLESS CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

OSTEOMED HEADLESS CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 2007-03-02, under 510(k) number K063298.

Who is the listed applicant for OSTEOMED HEADLESS CANNULATED SCREW SYSTEM?

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

What is the FDA product code for OSTEOMED HEADLESS CANNULATED SCREW SYSTEM?

The FDA product code for OSTEOMED HEADLESS CANNULATED SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Osteomed LP as applicant

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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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