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510(k) K151379

Conventus PRS System by Conventus Orthopaedics, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2015
Date Received
May 22, 2015
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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  • K161048 — Conventus Orthopaedics Ulna Fixation System (July 26, 2016)
  • K141737 — CONVENTUS PHS SYSTEM (April 8, 2015)
  • K131552 — CONVENTUS DRS (February 12, 2014)
  • K102689 — CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM (January 17, 2013)

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