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510(k) K092138

JTS EXTENDEABLE IMPLANT by Stanmore Implants Worldwide , Ltd. — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2011
Date Received
July 15, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

Other clearances by Stanmore Implants Worldwide , Ltd.

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  • K121765 — SCULPTOR ROBOTIC GUIDANCE ARM (RGA) (January 11, 2013)
  • K121056 — METS MODULAR PROXIMAL FEMUR (September 20, 2012)
  • K121029 — METS MODULAR DISTAL FEMUR (September 19, 2012)
  • K121055 — METS MODULAR TOTAL FEMUR (September 19, 2012)
  • K120992 — METS SMILES TOTAL KNEE REPLACEMENT (September 5, 2012)

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