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510(k) K121055

METS MODULAR TOTAL FEMUR by Stanmore Implants Worldwide , Ltd. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2012
Date Received
April 6, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Stanmore Implants Worldwide , Ltd.

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  • K121056 — METS MODULAR PROXIMAL FEMUR (September 20, 2012)
  • K121029 — METS MODULAR DISTAL FEMUR (September 19, 2012)
  • K120992 — METS SMILES TOTAL KNEE REPLACEMENT (September 5, 2012)
  • K092138 — JTS EXTENDEABLE IMPLANT (March 22, 2011)

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