LYS — Bone Mill Class I

FDA Device Classification

FDA product code LYS covers "Bone Mill", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LYS
Device Class
Class I
Regulation Number
888.4540
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K883183de medica mfgTRACER BONE MILLOctober 12, 1988
K860356zimmerORTHOBLEND POWERED BONE MILLJuly 8, 1986
K861164biodynamic technologiesOSTEOMILL BONE GRINDERMay 2, 1986
K860016aesculap instrumentsAESCULAP BONE MILLMarch 19, 1986