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510(k) K192919

Pinnacle Duofix HA Acetabular Cup Prosthesis by DePuy Orthopaedics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2019
Date Received
October 15, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by DePuy Orthopaedics, Inc.

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  • K203167 — DePuy Corail AMT Hip Prosthesis (November 19, 2020)
  • 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)
  • K192946 — DePuy Corail AMT Hip Prosthesis (November 26, 2019)
  • K182301 — PFC SIGMA Knee System (November 8, 2019)

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