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510(k) K080647

ACCIN BIPOLAR HEAD SYSTEM by Accelerated Innovation, LLC — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2008
Date Received
March 7, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

Other clearances by Accelerated Innovation, LLC

  • K081127 — ACCIN TOTAL KNEE SYSTEM (October 17, 2008)
  • K080539 — ACCIN UNIPOLAR HEAD SYSTEM (June 2, 2008)
  • K073120 — ACCIN PATELLOFEMORAL SYSTEM (February 29, 2008)
  • K073531 — ACCIN PEDICLE SCREW SYSTEM (February 4, 2008)
  • K073530 — ACCIN ANTERIOR CERVICAL PLATE SYSTEM (January 31, 2008)
  • K073068 — ACCIN HIP SYSTEM (January 10, 2008)

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