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510(k) K771744

OSTEOTOMES FOR CUTTING BONH by Depuy, Inc. — Product Code HWM

K771744 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "OSTEOTOMES FOR CUTTING BONH". The FDA issued a decision of Substantially Equivalent on September 28, 1977. The device falls under product code HWM (Osteotome), a Class I device regulated under 21 CFR 878.4800. Depuy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1977
Date Received
September 15, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Osteotome
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Depuy, Inc.

  • K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS (March 14, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
  • K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (July 22, 2004)
  • K033959 — LPS (July 1, 2004)
  • K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO (May 28, 2004)
  • K021478 — DELTA SHOULDER (November 18, 2003)
  • 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 HWM

  • K874503 — MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER (December 2, 1987)
  • K870780 — ACROMED WALLIE-HEINIG OSTEOTOMES (March 9, 1987)

FDA data resources