510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861164Substantially Equivalent

Osteomill Bone Grinder

Biodynamic Technologies, Inc., Arlington VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861164 is the FDA 510(k) clearance record for OSTEOMILL BONE GRINDER, a class I device, cleared for Biodynamic Technologies, Inc. on under FDA product code LYS (Bone Mill). FDA records list 30 510(k) clearances for Biodynamic Technologies, Inc., from to . As of , FDA records show no recalls naming K861164.

Clearance record

Decision date
Received
(35 days to decision)
Product code
LYS Bone Mill
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Biodynamic Technologies, Inc. 727 Twenty-Third St. S., Arlington VA
Third party review
No

Clearances, product code LYS

Trailing 12 months

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

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