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510(k) K993862

MODUS SAGITTAL SPLIT PLATE by The Straumann Co. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1999
Date Received
November 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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  • K943720 — ITI TRANSVERSAL SCREWING SYSTEM (March 24, 1995)
  • K931993 — ITI DISTANCE SYSTEM (April 26, 1994)

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