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510(k) K910712

VILLAN (VIDEO LIFT LINK ANALYSIS) by Physio Systems, Inc. — Product Code LXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1991
Date Received
February 20, 1991
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 Physio Systems, Inc.

  • K871557 — DISCIPLINE II RTD (August 26, 1987)
  • K870872 — DISCIPLINE I (March 23, 1987)

Other clearances for product code LXI

  • K930573 — SYNVASIVE CERAMIC SUTTING BLOCK (April 7, 1994)
  • 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)
  • K854254 — TENSION-ISOMETER (November 15, 1985)