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510(k) K213839

DePuy Corail AMT Hip Prosthesis by DePuy Orthopaedics, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2022
Date Received
December 9, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by DePuy Orthopaedics, Inc.

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  • K202472 — ACTIS Duofix Hip Prosthesis (October 21, 2020)
  • K201347 — DePuy ATTUNE™ Total Knee System (June 18, 2020)
  • K193540 — TRUMATCH Personalized Solutions (June 16, 2020)
  • K193398 — Summit DuoFix HA Coating (February 4, 2020)
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  • K192946 — DePuy Corail AMT Hip Prosthesis (November 26, 2019)
  • K182301 — PFC SIGMA Knee System (November 8, 2019)

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