The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Elibra Uni Soft-tissue Force Sensor, Model 61-xxxx(5 Models, Different Sizes.
| Device ID | K093046 |
| 510k Number | K093046 |
| Device Name: | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES |
| Classification | Intraoperative Orthopedic Joint Assessment Aid |
| Applicant | SYNVASIVE TECHNOLOGY, INC. 8726 FERRARA CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SYNVASIVE TECHNOLOGY, INC. 8726 FERRARA CT Naples, FL 34114 |
| Product Code | ONN |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-30 |
| Decision Date | 2011-03-22 |
| Summary: | summary |