Home / 510(k) Clearances / K790793

510(k) K790793

AMC R METACARPAL COMPONENT by Howmedica Corp. — Product Code KWN

K790793 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "AMC R METACARPAL COMPONENT". The FDA issued a decision of Substantially Equivalent on June 22, 1979. The device falls under product code KWN (Prosthesis, Wrist, Carpal Lunate), a Class II device regulated under 21 CFR 888.3750. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1979
Date Received
April 24, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Lunate
Device Class
Class II
Regulation Number
888.3750
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)
  • 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 KWN

  • K141920 — Wrist Hemiarthroplasty System (December 23, 2014)
  • K080997 — ASCENSION PYROCARBON LUNATE (June 17, 2008)
  • K050028 — MAESTRO CARPAL HEMIARTHROPLASTY (March 25, 2005)
  • K864491 — SWANSON TITANIUM CARPAL LUNATE IMPLANT (April 15, 1987)

FDA data resources