SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE— 510(k) K905451

Name: FDA 510(k) clearance K905451
Creator: U.S. Food and Drug Administration
Published: 1991-03-05

Substantially Equivalent

Advanced Osseous Technologies

FDA 510(k) clearance K905451 for SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE, Substantially Equivalent on 1991-03-05. Applicant: Advanced Osseous Technologies. Device class: 2.

Clearance details

Applicant: Advanced Osseous Technologies
Product code: Product code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 1990-12-05
Decision date: 1991-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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