Bone Mill
The Bone Mill (product code LYS) is an orthopedic surgical instrument used to grind autologous or allograft bone into small fragments or chips that can be used as bone graft material during spinal fusion, reconstructive, or other orthopedic procedures. Regulated under 21 CFR 888.4540 and classified as a Class 1 device subject only to general controls, it falls under the Orthopedic specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.
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Basic Information
- Product Code
- LYS
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K883183 | TRACER BONE MILL | Oct 12, 1988 | Substantially Equivalent | De Medica Mfg., Inc. |
| K860356 | ORTHOBLEND POWERED BONE MILL | Jul 08, 1986 | Substantially Equivalent | Zimmer, Inc. |
| K861164 | OSTEOMILL BONE GRINDER | May 02, 1986 | Substantially Equivalent | Biodynamic Technologies, Inc. |
| K860016 | AESCULAP BONE MILL | Mar 19, 1986 | Substantially Equivalent | Aesculap Instruments Corp. |
FEI Numbers
This FDA classification entry is associated with 83 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 83 registration numbers. Click on an entry to view related FDA registrations.