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FDA 510(k)

SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE

K-Number: K905451 · 1991-03-05

ApplicantAdvanced Osseous Technologies
Decision Date1991-03-05
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE 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 1991-03-05 under 510(k) number K905451. 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 SURGERY SYST/ORTHOPAEDIC USE?

SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE is a medical device that received FDA 510(k) clearance on 1991-03-05. The listed applicant is Advanced Osseous Technologies. The 510(k) number is K905451.

When did SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE receive FDA 510(k) clearance?

SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE received FDA 510(k) clearance on 1991-03-05, under 510(k) number K905451.

Who is the listed applicant for SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE?

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 SURGERY SYST/ORTHOPAEDIC USE?

The FDA product code for SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE 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 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.

K900003SYSTEM TEN MODEL 100 SURGICAL 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.

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