Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION

K-Number: K961725 · 1996-08-01

ApplicantC.L. Mcintosh & Assoc., Inc.
Decision Date1996-08-01
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION is the device name listed in this FDA 510(k) record. The listed applicant is C.L. Mcintosh & Assoc., Inc.. It received FDA 510(k) clearance on 1996-08-01 under 510(k) number K961725. 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 ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION?

OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION is a medical device that received FDA 510(k) clearance on 1996-08-01. The listed applicant is C.L. Mcintosh & Assoc., Inc.. The 510(k) number is K961725.

When did OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION receive FDA 510(k) clearance?

OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION received FDA 510(k) clearance on 1996-08-01, under 510(k) number K961725.

Who is the listed applicant for OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION?

The FDA 510(k) record lists C.L. Mcintosh & Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION?

The FDA product code for OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing C.L. Mcintosh & Assoc., 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.

K972016AUTIMO 2.5-D AND AUTIMO 3-DK970131ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICEK942227NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM

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.

↑