510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883183Substantially Equivalent

Tracer Bone Mill

De Medica Mfg., Inc., Santa Paula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883183 is the FDA 510(k) clearance record for TRACER BONE MILL, a class I device, cleared for De Medica Mfg., Inc. on under FDA product code LYS (Bone Mill). FDA records list 3 510(k) clearances for De Medica Mfg., Inc., from to . As of , FDA records show no recalls naming K883183.

Clearance record

Decision date
Received
(76 days to decision)
Product code
LYS Bone Mill
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
De Medica Mfg., Inc. 333 S. 11th St., Santa Paula CA
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