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510(k) K900926

TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) by Howmedica Corp. — Product Code LRN

K900926 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)". The FDA issued a decision of Substantially Equivalent on April 23, 1990. The device falls under product code LRN (Wire, Surgical), a Class II device regulated under 21 CFR 888.3030. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1990
Date Received
February 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Surgical
Device Class
Class II
Regulation Number
888.3030
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)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-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 LRN

  • K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (December 4, 2000)
  • K990355 — STAINLESS STEEL SOFT SUTURE WIRE (July 8, 1999)
  • K971682 — J-FX CERCLAGE SYSTEM (June 27, 1997)
  • K952783 — OXBORO-MEDICAL PIN COVERS (September 15, 1995)
  • K942603 — ORTHOPAEDIC WIRES (November 9, 1994)
  • K892651 — SONGER WIRING SYSTEM (July 25, 1989)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)

FDA data resources