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U.S. Department of Health and Human Services

Product Classification

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Device patient specific manual orthopedic stereotaxic system
Regulation Description Stereotaxic instrument.
Definition Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
Physical State Manual instrument and auxiliary software.
Technical Method Pre-operative imagery, such as CT or radiographs, is used to establish a correlation between the patient's AP plane and the instrument¿s plane.
Target Area Acetabulum
Regulation Medical Specialty Neurology
Review Panel Orthopedic
Product CodeOSF
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Restorative and Repair Devices Branch (RRDB)
Submission Type 510(k)
Regulation Number 882.4560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible