510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820995Substantially Equivalent

Magne-Field 400D Osteo-Bio-Netic Sys

Ludek Optics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820995 is the FDA 510(k) clearance record for MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS, a class II device, cleared for Ludek Optics, Inc. on under FDA product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer). FDA records list one 510(k) clearance for Ludek Optics, Inc. As of , FDA records show no recalls naming K820995.

Clearance record

Decision date
Received
(46 days to decision)
Product code
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3510
Device class
Class II
Review panel
Orthopedic
Applicant
Ludek Optics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KRO

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