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510(k) K811630

KINEMATIC ROTATING HINGE TOTAL KNEE PR. by Howmedica Corp. — Product Code LGE

K811630 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "KINEMATIC ROTATING HINGE TOTAL KNEE PR.". The FDA issued a decision of Substantially Equivalent on July 1, 1981. The device falls under product code LGE (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing), a Class II device regulated under 21 CFR 888.3530. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1981
Date Received
June 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
Device Class
Class II
Regulation Number
888.3530
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 LGE

  • K992346 — KINEMATIC II ROTATING HINGE KNEE (August 12, 1999)

FDA data resources