510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193398Substantially Equivalent

Summit DuoFix HA Coating

Depuy Orthopaedics Inc., Warsaw IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193398 is the FDA 510(k) clearance record for Summit DuoFix HA Coating, a class II device, cleared for DePuy Orthopaedics, Inc. on under FDA product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate). FDA records list 209 510(k) clearances for DePuy Orthopaedics, Inc., from to . As of , FDA records show no recalls naming K193398.

Clearance record

Decision date
Received
(60 days to decision)
Product code
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
DePuy Orthopaedics, Inc.
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEH

Trailing 12 months
2 clearances under product code MEH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260