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510(k) K123604

ABG III MONOLITHIC HIP STEM by Howmedica Osteonics Corp. — Product Code MAY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2013
Date Received
November 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K123166 — TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON A (February 14, 2013)
  • K122853 — NOVEL FIT AND FILL STEM (February 1, 2013)
  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)
  • K121308 — HIP SYSTEMS (July 30, 2012)
  • K120578 — ACCOLADE II HIP STEM (March 29, 2012)
  • K113409 — S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESS (February 15, 2012)

Other clearances for product code MAY

  • K110807 — ABG II MONOLITHIC HIP STEM (May 25, 2011)
  • K090103 — 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL (February 11, 2009)
  • K051844 — EQUATOR PLUS ACETABULAR CUP SYSTEM (October 7, 2005)