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510(k) K161048

Conventus Orthopaedics Ulna Fixation System by Conventus Orthopaedics, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2016
Date Received
April 14, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Conventus Orthopaedics, Inc.

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  • K131552 — CONVENTUS DRS (February 12, 2014)
  • K102689 — CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM (January 17, 2013)

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