Product code LYS
- Device name
- Bone Mill
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883183 | TRACER BONE MILL | De Medica Mfg., Inc. | 1988-10-12 |
| K860356 | ORTHOBLEND POWERED BONE MILL | Zimmer, Inc. | 1986-07-08 |
| K861164 | OSTEOMILL BONE GRINDER | Biodynamic Technologies, Inc. | 1986-05-02 |
| K860016 | AESCULAP BONE MILL | Aesculap Instruments Corp. | 1986-03-19 |
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| 00763000245801 | Midas Rex | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2022-04-03 |
| 00763000293741 | MIDAS REX BONE MILL | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2021-10-10 |
| 00763000293765 | Midas Rex | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2020-11-16 |
| ESAM14662001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| 10889950121532 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2020-03-17 |
| 10889950121525 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2020-03-17 |
| 10889950121518 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2020-03-17 |
| 00763000237790 | Midas Rex Legend | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2019-07-19 |
| 00613994204301 | Midas Rex™ | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2019-07-19 |
| 00763000237783 | Midas Rex Legend | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2019-07-04 |
| 10381780495277 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-24 |
| 10381780495307 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-24 |
| 10603295329671 | NA | DEPUY INTERNATIONAL LTD | 2018-09-24 |
| 10603295079996 | AML EXCEL | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 10603295080008 | AML EXCEL | DEPUY (IRELAND) | 2018-09-24 |
| 10603295080015 | AML EXCEL | DEPUY (IRELAND) | 2018-09-24 |
| 10603295080022 | AML EXCEL | DEPUY (IRELAND) | 2018-09-24 |
| 10603295143178 | SUMMIT | DEPUY (IRELAND) | 2018-09-24 |
| 10603295143185 | SUMMIT | DEPUY (IRELAND) | 2018-09-24 |
| 10603295329732 | NA | DEPUY INTERNATIONAL LTD | 2018-09-24 |
| 10603295329725 | NA | DEPUY INTERNATIONAL LTD | 2018-09-24 |
| 10603295329718 | NA | DEPUY INTERNATIONAL LTD | 2018-09-24 |
| 10603295329701 | NA | DEPUY INTERNATIONAL LTD | 2018-09-24 |
| 10603295329695 | NA | DEPUY INTERNATIONAL LTD | 2018-09-24 |
| 10603295329688 | NA | DEPUY INTERNATIONAL LTD | 2018-09-24 |
| 10603295329664 | NA | DEPUY INTERNATIONAL LTD | 2018-09-24 |
| 10381780501510 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-18 |
| 10381780506904 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-12 |
| M7161011370 | OrthoMedFlex | ORTHOMEDFLEX LLC | 2016-08-30 |
| M7161011380 | OrthoMedFlex | ORTHOMEDFLEX LLC | 2016-08-30 |