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510(k) K202472

ACTIS Duofix Hip Prosthesis by DePuy Orthopaedics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2020
Date Received
August 28, 2020
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)
  • K201347 — DePuy ATTUNE™ Total Knee System (June 18, 2020)
  • K193540 — TRUMATCH Personalized Solutions (June 16, 2020)
  • K193398 — Summit DuoFix HA Coating (February 4, 2020)
  • K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis (November 26, 2019)
  • K192946 — DePuy Corail AMT Hip Prosthesis (November 26, 2019)
  • K182301 — PFC SIGMA Knee System (November 8, 2019)

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