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510(k) K201831

CONFIDENCE Spinal Cement System by Depuy Spine, Inc. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2020
Date Received
July 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

Other clearances by Depuy Spine, Inc.

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  • K142185 — EXPEDIUM VERSE SPINE SYSTEM (November 19, 2014)
  • K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (June 14, 2012)
  • K121020 — VIPER SYSTEM (May 3, 2012)
  • K110353 — MOUNTAINEER OCT SPINAL SYSTEM (April 7, 2011)
  • K110216 — EXPEDIUM SYSTEM, VIPER SYSTEM (April 1, 2011)
  • K103133 — VEPER SYSTEM, EXPEDIUM SYSTEM (January 18, 2011)
  • K101993 — VIPER SYSTEM, EXPEDIUM SYSTEM (December 7, 2010)
  • K101923 — CONCORDE CURVE SYSTEM (December 1, 2010)
  • K103100 — MOUNTAINEER OCT SPINAL SYSTEM (November 17, 2010)

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  • K221697 — INJECTION PIN (KIP(02031-02061) (03031-03061)) (March 3, 2023)
  • K223294 — SpineJack® Expansion Kit (December 20, 2022)
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