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510(k) K770205

CEMENT CHISELS by Depuy, Inc. — Product Code HWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1977
Date Received
January 31, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Impactor
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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  • K033329 — DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (November 14, 2003)
  • K032151 — DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (September 26, 2003)
  • K020541 — AGILITY ANKLE REVISION PROSTHESIS (May 20, 2002)
  • K011810 — ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (September 7, 2001)

Other clearances for product code HWA

  • K933527 — MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (January 25, 1994)
  • K864422 — RAYLOR(TM) MALLET (November 24, 1986)
  • K841627 — MALLET (August 27, 1984)