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510(k) K090440

HINGE PEDIATRIC PLATING SYSTEM by Pega Medical, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2009
Date Received
February 20, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K111232 — GAP ENDO-EXO MEDULLARY SYSTEM (January 26, 2012)
  • K041393 — FASSIER-DUVAL TELSCOPIC IM SYSTEM (August 17, 2004)

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