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FDA 510(k)

EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL

K-Number: K002484 · 2000-10-04

ApplicantElectro Medical Systems SA
Decision Date2000-10-04
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL is the device name listed in this FDA 510(k) record. The listed applicant is Electro Medical Systems SA. It received FDA 510(k) clearance on 2000-10-04 under 510(k) number K002484. 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 EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL?

EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL is a medical device that received FDA 510(k) clearance on 2000-10-04. The listed applicant is Electro Medical Systems SA. The 510(k) number is K002484.

When did EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL receive FDA 510(k) clearance?

EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL received FDA 510(k) clearance on 2000-10-04, under 510(k) number K002484.

Who is the listed applicant for EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL?

The FDA 510(k) record lists Electro Medical Systems SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL?

The FDA product code for EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL is JDX.

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Other records listing Electro Medical Systems SA 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.

K022328EMS PIEZON MASTER 600K022119EMS AIR-FLOW HANDY 2 DENTAL HANDPIECEK012445EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)K992251SWISS LITHOCLAST MULTIPURPOSE PROBEK963285EMS SWISS LITHOCLAST LITHOTRIPTERK964111LITHOVAC SUCTION/ASPIRATION PROBE

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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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