510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K871462Substantially Equivalent for Some Indications

Prosthetic - Femoral Hip Component

Louis A. Serafin, Jr., M.D., Port Huron MI / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K871462 is the FDA 510(k) clearance record for PROSTHETIC - FEMORAL HIP COMPONENT, a class II device, cleared for Louis A. Serafin, Jr., M.D. on under FDA product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented). FDA records list one 510(k) clearance for Louis A. Serafin, Jr., M.D. As of , FDA records show no recalls naming K871462.

Clearance record

Decision date
Received
(51 days to decision)
Product code
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation
21 CFR 888.3350
Device class
Class II
Review panel
Orthopedic
Applicant
Louis A. Serafin, Jr., M.D. 3315 Berry Dr., Port Huron MI
Third party review
No

Clearances, product code JDI

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