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510(k) K854254

TENSION-ISOMETER by Medmetric Corp. — Product Code LXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1985
Date Received
October 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Drill, Ligament
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Medmetric Corp.

  • K943197 — KT1000/S KNEE LIGAMENT ARTHROMETER (March 2, 1995)
  • K942059 — KT2000 KNEE LIGAMENT ARTHROMETER (September 20, 1994)
  • K904823 — FLEXERCYCLE (January 30, 1991)
  • K904898 — TORQUE FRAME QTF1000 (November 28, 1990)
  • K812806 — KT-1000 DEVICE (November 10, 1981)
  • K812713 — DRAWER TEST (November 5, 1981)
  • K801572 — SURG-ASSIST (August 4, 1980)

Other clearances for product code LXI

  • K930573 — SYNVASIVE CERAMIC SUTTING BLOCK (April 7, 1994)
  • K910712 — VILLAN (VIDEO LIFT LINK ANALYSIS) (May 21, 1991)
  • K892655 — ACL DRILL GUIDE SYSTEM (September 28, 1989)
  • K890445 — PERSONAL ALERT ASSIST DEVICE (May 19, 1989)
  • K882407 — BOW & ARROW DRILL GUIDE (September 6, 1988)
  • K881378 — PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (June 17, 1988)
  • K880739 — DYONICS DRILL GUIDE/ISOMETER SYSTEM (March 21, 1988)