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FDA 510(k)

STS SCREW

K-Number: K032682 · 2003-10-22

ApplicantOrtho-Pro, LLC
Decision Date2003-10-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STS SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Pro, LLC. It received FDA 510(k) clearance on 2003-10-22 under 510(k) number K032682. 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 STS SCREW?

STS SCREW is a medical device that received FDA 510(k) clearance on 2003-10-22. The listed applicant is Ortho-Pro, LLC. The 510(k) number is K032682.

When did STS SCREW receive FDA 510(k) clearance?

STS SCREW received FDA 510(k) clearance on 2003-10-22, under 510(k) number K032682.

Who is the listed applicant for STS SCREW?

The FDA 510(k) record lists Ortho-Pro, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STS SCREW?

The FDA product code for STS SCREW 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 Ortho-Pro, LLC 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.

K102601ORTHOFLEX RODK094037TC PLATING SYSTEMK042310ORTHO-PRO CANNULATED BONE SCREWS

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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