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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device absorbable gel for intraoperative use in spine surgery
Definition This device is an absorbable gel implant for intraoperative use in spinal procedures that is applied to nerve roots after hemostasis has been achieved and prior to closure. The device is intended as an adjunct to the surgical procedure to reduce pain and neurological symptoms.
Product CodeQVL
Regulation Number 888.3047
Device Class 2


Premarket Reviews
ManufacturerDecision
FZIOMED, INC.
  GRANTED 1

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