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FDA 510(k)

ORTHO-PRO CANNULATED BONE SCREWS

K-Number: K042310 · 2004-09-16

ApplicantOrtho-Pro, LLC
Decision Date2004-09-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHO-PRO CANNULATED BONE SCREWS 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 2004-09-16 under 510(k) number K042310. 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 ORTHO-PRO CANNULATED BONE SCREWS?

ORTHO-PRO CANNULATED BONE SCREWS is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is Ortho-Pro, LLC. The 510(k) number is K042310.

When did ORTHO-PRO CANNULATED BONE SCREWS receive FDA 510(k) clearance?

ORTHO-PRO CANNULATED BONE SCREWS received FDA 510(k) clearance on 2004-09-16, under 510(k) number K042310.

Who is the listed applicant for ORTHO-PRO CANNULATED BONE SCREWS?

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 ORTHO-PRO CANNULATED BONE SCREWS?

The FDA product code for ORTHO-PRO CANNULATED BONE SCREWS is HWC. This falls under the Cardiovascular category.

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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 SYSTEMK032682STS SCREW

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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