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510(k) K113122

PIPELINE CR PRIMARY KNEE SYSTEM by Pipeline Orthopedics — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2012
Date Received
October 21, 2011
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 Pipeline Orthopedics

  • K131368 — NEO KNEE SYSTEM (October 3, 2013)
  • K132046 — PIPELINE KNEE SYSTEM (September 23, 2013)
  • K130353 — PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) (July 1, 2013)
  • K131237 — PIPELINE TOTAL HIP SYSTEM (June 13, 2013)
  • K123692 — PIPELINE KNEE SYSTEM (May 24, 2013)
  • K122500 — NEO PS KNEE SYSTEM (May 3, 2013)
  • K120313 — NEO CR KNEE SYSTEM (April 20, 2012)
  • K112802 — PIPELINE TOTAL HIP SYSTEM (March 9, 2012)

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