Synthes Hemostatic Bone Putty (Hbp)

• • Terminated Z-2206-2012 FDA Class I ·initiated 5 Jul 2012

  There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.

510(k) Number

K103822 ↗

FDA Product Code

MTJ

FDA applicant

Synthes USA Products, LLC

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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