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510(k) K990712

OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM by Howmedica Osteonics Corp. — Product Code MJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1999
Date Received
March 4, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
Device Class
Class III
Regulation Number
Review Panel
OR
Submission Type

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  • K130895 — REUNION RSA SHOULDER SYSTEM (December 27, 2013)
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  • 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)

Other clearances for product code MJT

  • K982418 — BUECHEL-PAPPAS MODULAR SALVAGE STEM (April 29, 1999)
  • K960363 — BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101 (February 18, 1997)