The following data is part of a premarket notification filed by Kamm & Associates with the FDA for Elibra Soft-tissue Force Sensor.
| Device ID | K132104 |
| 510k Number | K132104 |
| Device Name: | ELIBRA SOFT-TISSUE FORCE SENSOR |
| Classification | Intraoperative Orthopedic Joint Assessment Aid |
| Applicant | Kamm & Associates 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. Kamm & Associates 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | ONN |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-08 |
| Decision Date | 2014-03-21 |
| Summary: | summary |