510(k) K170698

ALLY(TM) Bone Screws by Providence Medical Technology, Inc. — Product Code HWC

K170698 is an FDA 510(k) premarket notification submitted by Providence Medical Technology, Inc. for the device "ALLY(TM) Bone Screws". The FDA issued a decision of Substantially Equivalent on May 31, 2017. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Providence Medical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2017
Date Received
March 7, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type