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FDA 510(k)

SYSTEM TEN MODEL 100 SURGICAL SYSTEM

K-Number: K900003 · 1990-03-16

ApplicantAdvanced Osseous Technologies
Decision Date1990-03-16
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYSTEM TEN MODEL 100 SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Osseous Technologies. It received FDA 510(k) clearance on 1990-03-16 under 510(k) number K900003. 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 SYSTEM TEN MODEL 100 SURGICAL SYSTEM?

SYSTEM TEN MODEL 100 SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1990-03-16. The listed applicant is Advanced Osseous Technologies. The 510(k) number is K900003.

When did SYSTEM TEN MODEL 100 SURGICAL SYSTEM receive FDA 510(k) clearance?

SYSTEM TEN MODEL 100 SURGICAL SYSTEM received FDA 510(k) clearance on 1990-03-16, under 510(k) number K900003.

Who is the listed applicant for SYSTEM TEN MODEL 100 SURGICAL SYSTEM?

The FDA 510(k) record lists Advanced Osseous Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM TEN MODEL 100 SURGICAL SYSTEM?

The FDA product code for SYSTEM TEN MODEL 100 SURGICAL SYSTEM 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 Advanced Osseous Technologies 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.

K905451SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE

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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