Definition: Measurement And Interpretation Of Orthopedic Joint Information.
| Device Type ID | 4457 |
| Device Name | Intraoperative Orthopedic Joint Assessment Aid |
| Physical State | Measurement Transducer, Central Processing Unit, And User Interface. |
| Technical Method | The System Analytically Measures The Joint State And Interprets The Measurements Using A Software Algorithm To Aid In The Positioning Of An Implant System. |
| Target Area | Orthopedic Joint. |
| Regulation Description | Stereotaxic Instrument. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ONN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4457 |
| Device | Intraoperative Orthopedic Joint Assessment Aid |
| Product Code | ONN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stereotaxic Instrument. |
| CFR Regulation Number | 882.4560 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KAMM & ASSOCIATES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHOSENSOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Orthosensor, Inc. | II | Oct-05-2018 |
| 2 | Orthosensor, Inc. | II | Jan-29-2015 |