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FDA 510(k)

OSCAR, MODEL OE3000

K-Number: K021502 · 2002-06-06

ApplicantOrthosonics, Ltd.
Decision Date2002-06-06
Product CodeLZV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSCAR, MODEL OE3000 is the device name listed in this FDA 510(k) record. The listed applicant is Orthosonics, Ltd.. It received FDA 510(k) clearance on 2002-06-06 under 510(k) number K021502. The device is classified under product code LZV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSCAR, MODEL OE3000?

OSCAR, MODEL OE3000 is a medical device that received FDA 510(k) clearance on 2002-06-06. The listed applicant is Orthosonics, Ltd.. The 510(k) number is K021502.

When did OSCAR, MODEL OE3000 receive FDA 510(k) clearance?

OSCAR, MODEL OE3000 received FDA 510(k) clearance on 2002-06-06, under 510(k) number K021502.

Who is the listed applicant for OSCAR, MODEL OE3000?

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

What is the FDA product code for OSCAR, MODEL OE3000?

The FDA product code for OSCAR, MODEL OE3000 is LZV.

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 Orthosonics, 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.

K093805OSCAR 3K083830OSCAR BONE RESECTORK051053OSCAR, MODEL OE3000DB

Related Devices (Code: LZV)

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.

K961101STRYKER CEMENT REMOVAL SYSTEMStryker Corp.K930629ACRYL-X II SYSTEMSonokinetics, Inc.K904156ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITSOrigin Medsystems, Inc.K904180PROSTHETIC CEMENT REMOVEROrigin Medsystems, Inc.K891472IMPLANT TECHNOLOGY BONE CEMENT EXTRACTORImplant Technology, Inc.K890285PROSTHETIC CEMENT REMOVERAlbert K. Chin

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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