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510(k) K190837

Internal Hex Implant System by Ebi, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2020
Date Received
April 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Ebi, Inc.

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  • K113796 — SOLITAIRE-C CERVICAL SPACER SYSTEM (April 26, 2012)
  • K111376 — CONSTRUX EXTERNAL FIXATION DEVICE (August 3, 2011)
  • K073116 — EBI INTERNAL IMPLANT SYSTEM (February 28, 2008)

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