Cleared Traditional

K103822 - SYNTHES HEMOSTATIC BONE PUTTY (HBP) (FDA 510(k) Clearance)

K103822 · Synthes USA Products, LLC · General & Plastic Surgery device

May 2011

Decision

140d

Days

—

Risk

K103822 is an FDA 510(k) clearance for the SYNTHES HEMOSTATIC BONE PUTTY (HBP). This device is classified as a Wax, Bone.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on May 19, 2011, 140 days after receiving the submission on December 30, 2010.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K103822 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 30, 2010
Decision Date	May 19, 2011
Days to Decision	140 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF