510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K972931Substantially Equivalent

Plus Epf Acetabular Cup

Hhl Consulting, Foster City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972931 is the FDA 510(k) clearance record for PLUS EPF ACETABULAR CUP, a class II device, cleared for Hhl Consulting on under FDA product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list one 510(k) clearance for Hhl Consulting. As of , FDA records show no recalls naming K972931.

Clearance record

Decision date
Received
(97 days to decision)
Product code
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Hhl Consulting 835 Cortez Ln., Foster City CA
510(k) summary
Summary
Third party review
No

Clearances, product code LWJ

Trailing 12 months

FDA records hold no clearances under product code LWJ in the trailing twelve months.

FDA records show no clearances under product code LWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260