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FDA 510(k)

OSV II

K-Number: K081773 · 2008-11-06

ApplicantIntegra Neurosciences Implants S.A.
Decision Date2008-11-06
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSV II is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurosciences Implants S.A.. It received FDA 510(k) clearance on 2008-11-06 under 510(k) number K081773. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSV II?

OSV II is a medical device that received FDA 510(k) clearance on 2008-11-06. The listed applicant is Integra Neurosciences Implants S.A.. The 510(k) number is K081773.

When did OSV II receive FDA 510(k) clearance?

OSV II received FDA 510(k) clearance on 2008-11-06, under 510(k) number K081773.

Who is the listed applicant for OSV II?

The FDA 510(k) record lists Integra Neurosciences Implants S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSV II?

The FDA product code for OSV II is JXG.

Other records listing Integra Neurosciences Implants S.A. 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.

K042558EQUI-FLOW VALVE AND SHUNT SYSTEMK042192LOW FLOW OSV II HYDROCEPHALUS VALVEK040201MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEMK033698CONTOUR-FLEX VALVE AND SHUNT SYSTEMK032817EXTERNAL DRAINAGE SET

Related Devices (Code: JXG)

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.

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

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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