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FDA 510(k)

N-FORCE FIXATION SYSTEM

K-Number: K102528 · 2011-07-28

ApplicantInnovision, Inc.
Decision Date2011-07-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

N-FORCE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innovision, Inc.. It received FDA 510(k) clearance on 2011-07-28 under 510(k) number K102528. 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 N-FORCE FIXATION SYSTEM?

N-FORCE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-28. The listed applicant is Innovision, Inc.. The 510(k) number is K102528.

When did N-FORCE FIXATION SYSTEM receive FDA 510(k) clearance?

N-FORCE FIXATION SYSTEM received FDA 510(k) clearance on 2011-07-28, under 510(k) number K102528.

Who is the listed applicant for N-FORCE FIXATION SYSTEM?

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

What is the FDA product code for N-FORCE FIXATION SYSTEM?

The FDA product code for N-FORCE 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 Innovision, Inc. 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.

K011914HYDRO2, HS-75K000485HYDRO2, HS-75K944223ACCUCON

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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