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510(k) K980999

ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT by Instrument Makar, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1998
Date Received
March 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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  • K960555 — BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR (July 9, 1996)
  • K943249 — BIOABSORBABLE INTERFERENCE SCREW (July 31, 1995)
  • K944062 — LAPRASCOPIC GRASPER (February 23, 1995)
  • K942828 — MAKAR FULL AND HALF FACE SHIELD (February 23, 1995)
  • K930980 — INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW (February 10, 1994)
  • K923841 — BONE SCREWS (October 27, 1993)

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