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510(k) K781955

GUN, CEMENT by Depuy, Inc. — Product Code KIH

K781955 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "GUN, CEMENT". The FDA issued a decision of Substantially Equivalent on December 4, 1978. The device falls under product code KIH (Dispenser, Cement), a Class I device regulated under 21 CFR 888.4200. Depuy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1978
Date Received
November 21, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dispenser, Cement
Device Class
Class I
Regulation Number
888.4200
Review Panel
OR
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 KIH

  • K042591 — SMARTMIX PRE-FILLED MIXING SYSTEM (October 22, 2004)
  • K943906 — P.F.C. CEMENT PRESSURIZING SYSTEM (December 21, 1994)
  • K897134 — CMW CEMENT PRESSURISATION SYSTEM (March 2, 1990)
  • K851881 — ORTHOPEADIC CEMENT DELIVERY SYSTEM (June 13, 1985)
  • K840046 — PRESSURIZING/SCAVENGING ACRYLIC CEMENT (February 9, 1984)
  • K833675 — BRIGHAM TIBIAL CEMENT PRESSURIZER (December 12, 1983)
  • K811317 — HOWMEDICA FEMORAL PRESSURING SEAL (May 29, 1981)
  • K801388 — OH-HARRIS (July 28, 1980)
  • K790275 — GUN, EXETER CEMENT (February 21, 1979)
  • K780266 — BONE CEMENT APPLICATOR (February 28, 1978)

FDA data resources