FDA product code LYS: Bone Mill
LYS is the FDA product code for bone mill. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 4 510(k) submissions under LYS, from 4 different applicants. The average 510(k) review took 86 days (median 76). FDA has posted 1 recall for LYS devices.
Classification
| Field | Value |
|---|---|
| Device name | Bone Mill |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LYS clearance
Top LYS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| De Medica Mfg., Inc. | 1 | 1988-10-12 |
| Zimmer, Inc. | 1 | 1986-07-08 |
| Biodynamic Technologies, Inc. | 1 | 1986-05-02 |
| Aesculap Instruments Corp. | 1 | 1986-03-19 |
Most recent LYS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883183 | De Medica Mfg., Inc. | TRACER BONE MILL | 1988-10-12 | 76 |
| K860356 | Zimmer, Inc. | ORTHOBLEND POWERED BONE MILL | 1986-07-08 | 159 |
| K861164 | Biodynamic Technologies, Inc. | OSTEOMILL BONE GRINDER | 1986-05-02 | 35 |
| K860016 | Aesculap Instruments Corp. | AESCULAP BONE MILL | 1986-03-19 | 75 |
Recalls for LYS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-10-20.
Frequently asked questions
What is FDA product code LYS?
LYS is the FDA product code for bone mill. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is LYS?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LYS?
Across 4 cleared submissions the average was 86 days from receipt to decision (median 76).
Which companies have the most LYS clearances?
De Medica Mfg., Inc. (1); Zimmer, Inc. (1); Biodynamic Technologies, Inc. (1); Aesculap Instruments Corp. (1).
Have LYS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-10-20.
Next steps
- Run an FDA pathway report with predicate devices for product code LYS
- Run a recall and safety report across every LYS manufacturer
- Watch product code LYS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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