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FDA 510(k)

OSCAR, MODEL OE3000DB

K-Number: K051053 · 2005-07-21

ApplicantOrthosonics, Ltd.
Decision Date2005-07-21
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSCAR, MODEL OE3000DB is the device name listed in this FDA 510(k) record. The listed applicant is Orthosonics, Ltd.. It received FDA 510(k) clearance on 2005-07-21 under 510(k) number K051053. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSCAR, MODEL OE3000DB?

OSCAR, MODEL OE3000DB is a medical device that received FDA 510(k) clearance on 2005-07-21. The listed applicant is Orthosonics, Ltd.. The 510(k) number is K051053.

When did OSCAR, MODEL OE3000DB receive FDA 510(k) clearance?

OSCAR, MODEL OE3000DB received FDA 510(k) clearance on 2005-07-21, under 510(k) number K051053.

Who is the listed applicant for OSCAR, MODEL OE3000DB?

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 OE3000DB?

The FDA product code for OSCAR, MODEL OE3000DB is JDX.

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 RESECTORK021502OSCAR, MODEL OE3000

Related Devices (Code: JDX)

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.

K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research ConsortiumK163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon GroupK153743PIEZOSURGERY PLUSMectron S.P.A.K132848PIEZOSURGERY FLEXMectron S.P.A.K100410PIEZOELECTRIC SYSTEMSatelec

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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