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510(k) K032052

UC-PLUS SOLUTION UNICONDYLAR KNEE by Plus Orthopedics — Product Code HRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2003
Date Received
July 2, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
Review Panel
OR
Submission Type

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  • K070278 — POLARCUP DUAL MOBILITY SYSTEM (April 16, 2007)
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  • K061362 — PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM (October 6, 2006)
  • K032126 — PROMOS SHOULDER (January 8, 2004)
  • K033763 — MODIFICATION TO SLIM GLIDING NAIL SYSTEM (December 18, 2003)
  • K032709 — MODULAR PLUS HIP STEM (September 23, 2003)
  • K032548 — IP-XS COMPRESSION NAIL SYSTEM (September 10, 2003)
  • K032215 — VKS/TC-PLUS REVISION KNEE (August 8, 2003)

Other clearances for product code HRY

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  • K152631 — MPO Total Knee Systems MR Labeling (March 23, 2016)
  • K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM (March 20, 2015)
  • K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (March 28, 2014)
  • K131167 — UNIVATION (October 17, 2013)
  • K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) (October 22, 2012)
  • K110415 — SIGNATURE PLANNER / SIGNATURE GUIDES (May 16, 2011)
  • K100973 — EVOLUTION UNICONDYLAR KNEE SYSTEM (August 10, 2010)
  • K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (October 3, 2008)