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510(k) K963940

EXETER MESH by Howmedica, Inc. — Product Code JDJ

K963940 is an FDA 510(k) premarket notification submitted by Howmedica, Inc. for the device "EXETER MESH". The FDA issued a decision of Substantially Equivalent on February 13, 1997. The device falls under product code JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis), a Class II device regulated under 21 CFR 878.3300. Howmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1997
Date Received
October 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

Other clearances by Howmedica, Inc.

  • 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)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)

Other clearances for product code JDJ

  • K972760 — LINK, ACETABULAR REVISION MESH CUP (October 22, 1997)
  • K970957 — OSTEONICS RESTORATION ACETABULAR RING (June 3, 1997)
  • K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGS (September 17, 1996)
  • K962007 — PROTRUSION CAGES (August 1, 1996)
  • K925883 — OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS (June 15, 1993)
  • K890450 — INTERMEDICS APR(TM) II FEMORAL COMPONENT (August 9, 1989)

FDA data resources