510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K943230Substantially Equivalent

Mayo Hip Prosthesis

Mayo Clinic, Rocehster MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943230 is the FDA 510(k) clearance record for MAYO HIP PROSTHESIS, a class II device, cleared for Mayo Clinic on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 3 510(k) clearances for Mayo Clinic, from to . As of , FDA records show no recalls naming K943230.

Clearance record

Decision date
Received
(923 days to decision)
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Mayo Clinic 200 First St. SW, Rocehster MN
510(k) summary
Summary
Third party review
No

Clearances, product code LPH

Trailing 12 months
11 clearances under product code LPH in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LPH, trailing twelve months
MonthClearances
November 20252
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20261
August 20262
September 20261
October 20260