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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOSF
Regulation Number 882.4560
Device Class 2

Recalls
Manufacturer Recall Class Date Posted
1 Materialise N.V. II Oct-23-2015

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