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FDA 510(k)

CSTS SCREW

K-Number: K093055 · 2010-11-22

ApplicantOrthopro, LLC
Decision Date2010-11-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CSTS SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Orthopro, LLC. It received FDA 510(k) clearance on 2010-11-22 under 510(k) number K093055. 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 CSTS SCREW?

CSTS SCREW is a medical device that received FDA 510(k) clearance on 2010-11-22. The listed applicant is Orthopro, LLC. The 510(k) number is K093055.

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

CSTS SCREW received FDA 510(k) clearance on 2010-11-22, under 510(k) number K093055.

Who is the listed applicant for CSTS SCREW?

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

What is the FDA product code for CSTS SCREW?

The FDA product code for CSTS SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Orthopro, 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.

K122936ANKLE TRAUMA SYSTEMK113006I-FUSE HAMMER TOE SYSTEMSK073228DC ULNAR SHORTENING SYSTEMK070555ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRESK071243METAL HEMI IMPLANTK062908ORTHROPRO HEMI TOE

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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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