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FDA 510(k)

INION CPS BSSO SCREW

K-Number: K020266 · 2002-02-22

ApplicantInion , Ltd.
Decision Date2002-02-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INION CPS BSSO SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Inion , Ltd.. It received FDA 510(k) clearance on 2002-02-22 under 510(k) number K020266. 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 INION CPS BSSO SCREW?

INION CPS BSSO SCREW is a medical device that received FDA 510(k) clearance on 2002-02-22. The listed applicant is Inion , Ltd.. The 510(k) number is K020266.

When did INION CPS BSSO SCREW receive FDA 510(k) clearance?

INION CPS BSSO SCREW received FDA 510(k) clearance on 2002-02-22, under 510(k) number K020266.

Who is the listed applicant for INION CPS BSSO SCREW?

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

What is the FDA product code for INION CPS BSSO SCREW?

The FDA product code for INION CPS BSSO SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Inion , Ltd. 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.

K071810INION SPINAL GRAFT CONTAINMENT SYSTEMK063410INION CPS/OTPS FREEDOMPLATEK062617MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEMK060393INION HEXALON BIODEGRADABLE ACL/PCL SCREWK051821INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEMK052624INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE

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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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