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510(k) K132158

NOVOHIP TOTAL HIP SYSTEM by Novosource, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2014
Date Received
July 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
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)
  • K131398 — NOVOKNEE TOTAL KNEE SYSTEM (September 16, 2013)
  • K123339 — TK1 TOTAL KNEE SYSTEM (April 11, 2013)

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