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510(k) K141377

BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD by Merete Medical GmbH — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2014
Date Received
May 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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  • K120787 — MERETE LOCKING BONE PLATE SYSTEM III (November 27, 2012)
  • K120978 — OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR (May 2, 2012)

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