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510(k) K833675

BRIGHAM TIBIAL CEMENT PRESSURIZER by Howmedica Corp. — Product Code KIH

K833675 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "BRIGHAM TIBIAL CEMENT PRESSURIZER". The FDA issued a decision of Substantially Equivalent on December 12, 1983. The device falls under product code KIH (Dispenser, Cement), a Class I device regulated under 21 CFR 888.4200. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1983
Date Received
October 18, 1983
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 Howmedica Corp.

  • K984251 — XIA SPINE SYSTEM (February 24, 1999)
  • K984202 — HOWMEDICA HUMERAL INTERCALARY SYSTEM (February 5, 1999)
  • K984305 — ZETA MULTIZONE LOCKING NAIL SYSTEM (February 1, 1999)
  • K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (January 29, 1999)
  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
  • K983404 — TYPE 3 FEMORAL COMPONENTS (December 22, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)

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)
  • K811317 — HOWMEDICA FEMORAL PRESSURING SEAL (May 29, 1981)
  • K801388 — OH-HARRIS (July 28, 1980)
  • K790275 — GUN, EXETER CEMENT (February 21, 1979)
  • K781955 — GUN, CEMENT (December 4, 1978)
  • K780266 — BONE CEMENT APPLICATOR (February 28, 1978)

FDA data resources