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FDA 510(k)

LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)

K-Number: K072961 · 2007-12-19

ApplicantSra Developments, Ltd.
Decision Date2007-12-19
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) is the device name listed in this FDA 510(k) record. The listed applicant is Sra Developments, Ltd.. It received FDA 510(k) clearance on 2007-12-19 under 510(k) number K072961. 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 LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)?

LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) is a medical device that received FDA 510(k) clearance on 2007-12-19. The listed applicant is Sra Developments, Ltd.. The 510(k) number is K072961.

When did LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) receive FDA 510(k) clearance?

LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) received FDA 510(k) clearance on 2007-12-19, under 510(k) number K072961.

Who is the listed applicant for LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)?

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

What is the FDA product code for LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)?

The FDA product code for LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) 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 Sra Developments, 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.

K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5K063531SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEMK032424LOTUS

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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