Home / 510(k) Clearances / K153587

510(k) K153587

Taps for Resorbable Screws by Synthes (USA) Products, LLC — Product Code HBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2017
Date Received
December 16, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Manual)
Device Class
Class II
Regulation Number
882.4300
Review Panel
NE
Submission Type

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  • K915546 — PS MEDICAL VENTRICULOSTOMY KIT (December 30, 1991)