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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
Definition Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
Product CodeOSF
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
SURGICAL PLANNING ASSOCIATES, INC
  SUBSTANTIALLY EQUIVALENT 2

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