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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instruments designed for press-fit osteochondral implants
Definition The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.
Product CodeQBO
Regulation Number 888.4505
Device Class 2


Premarket Reviews
ManufacturerDecision
CARTIVA, INC.
  SUBSTANTIALLY EQUIVALENT 1


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