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510(k) K131398

NOVOKNEE TOTAL KNEE SYSTEM by Novosource, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2013
Date Received
May 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Novosource, Inc.

  • K140701 — NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG (June 27, 2014)
  • K132158 — NOVOHIP TOTAL HIP SYSTEM (February 21, 2014)
  • K123339 — TK1 TOTAL KNEE SYSTEM (April 11, 2013)

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