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510(k) K930573

SYNVASIVE CERAMIC SUTTING BLOCK by Synvasive Technology, Inc. — Product Code LXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1994
Date Received
February 4, 1993
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

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Other clearances for product code LXI

  • 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)
  • K854254 — TENSION-ISOMETER (November 15, 1985)