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510(k) K052237

SC CERAMIC BALL HEADS by Orthopedic Alliance, LLC — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2005
Date Received
August 17, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Orthopedic Alliance, LLC

  • K033826 — ORTHOPEDIC ALLIANCE SPINE SYSTEM (July 1, 2004)
  • K031474 — SC TOTAL HIP SYSTEM (October 15, 2003)

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