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510(k) K180087

A.M. Surgical Intramedullary Fixation Device by A.M. Surgical, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2018
Date Received
January 12, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by A.M. Surgical, Inc.

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  • K982142 — MOUNTABLE ENDOSCOPIC KNIFE (December 30, 1998)

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