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

Bone Mill

21 CFR 888.4540 / Orthopedic
FDA source (opens on fda.gov)

LYS is the FDA product code for Bone Mill, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LYS
Device name
Bone Mill
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code LYS

By decision year
4 clearances under product code LYS with a decision year between 1986 and 1988, 1986 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LYS by decision year
YearClearances
19863
19881

Applicants with the most clearances

Product code LYS
Applicants holding the most 510(k) clearances under product code LYS
ApplicantClearances
Aesculap Instruments Corp.1
Biodynamic Technologies, Inc.1
De Medica Mfg., Inc.1
Zimmer GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 79 companies shown, in name order