510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896580Substantially Equivalent

Uni-Polar Head

Richards Medical Co., Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896580 is the FDA 510(k) clearance record for UNI-POLAR HEAD, a class II device, cleared for Richards Medical Co., Inc. on under FDA product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball). FDA records list 71 510(k) clearances for Richards Medical Co., Inc., from to . As of , FDA records show no recalls naming K896580.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Richards Medical Co., Inc. 1450 Brooks Rd., Memphis TN
Third party review
No

Clearances, product code LZY

Trailing 12 months

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

FDA records show no clearances under product code LZY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LZY, 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