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510(k) K200782

Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite by Howmedica Osteonics Corp. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2020
Date Received
March 26, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

Other clearances by Howmedica Osteonics Corp.

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  • K130895 — REUNION RSA SHOULDER SYSTEM (December 27, 2013)
  • K123604 — ABG III MONOLITHIC HIP STEM (August 16, 2013)
  • K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CI (February 22, 2013)
  • 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)

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