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FDA 510(k)

PRO FIXATION SYSTEM

K-Number: K110538 · 2011-07-12

ApplicantSynovis Orthopedic & Woundcare
Decision Date2011-07-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRO FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Orthopedic & Woundcare. It received FDA 510(k) clearance on 2011-07-12 under 510(k) number K110538. 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 PRO FIXATION SYSTEM?

PRO FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-12. The listed applicant is Synovis Orthopedic & Woundcare. The 510(k) number is K110538.

When did PRO FIXATION SYSTEM receive FDA 510(k) clearance?

PRO FIXATION SYSTEM received FDA 510(k) clearance on 2011-07-12, under 510(k) number K110538.

Who is the listed applicant for PRO FIXATION SYSTEM?

The FDA 510(k) record lists Synovis Orthopedic & Woundcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO FIXATION SYSTEM?

The FDA product code for PRO FIXATION SYSTEM 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 Synovis Orthopedic & Woundcare 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.

K113460SYNERGY TISSUE MATRIXK112399UNITE BIOMATRIX

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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