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FDA 510(k)

ITM SONIC SURGERY SYSTEM

K-Number: K912931 · 1991-10-03

ApplicantBuckman Co., Inc.
Decision Date1991-10-03
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ITM SONIC SURGERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1991-10-03 under 510(k) number K912931. 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 ITM SONIC SURGERY SYSTEM?

ITM SONIC SURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-03. The listed applicant is Buckman Co., Inc.. The 510(k) number is K912931.

When did ITM SONIC SURGERY SYSTEM receive FDA 510(k) clearance?

ITM SONIC SURGERY SYSTEM received FDA 510(k) clearance on 1991-10-03, under 510(k) number K912931.

Who is the listed applicant for ITM SONIC SURGERY SYSTEM?

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

What is the FDA product code for ITM SONIC SURGERY SYSTEM?

The FDA product code for ITM SONIC SURGERY SYSTEM is JDX.

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Other records listing Buckman Co., 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.

K961320CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEMK974641FUTURELASE 3000/3002 ERBIUM LASER SYSTEMK964252ORTHOCHUCKK950099SYNERGY(TM) TI POSTERIOR SPINAL SYSTEMK960451WEBB-MORLEY SPINE SYSTEMK950999KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS

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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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