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510(k) K881378

PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE by Pfizer, Inc. — Product Code LXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1988
Date Received
April 1, 1988
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

  • 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)
  • K880739 — DYONICS DRILL GUIDE/ISOMETER SYSTEM (March 21, 1988)
  • K854254 — TENSION-ISOMETER (November 15, 1985)