The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Elibra Dynamic Knee Balancer.
| Device ID | K070108 |
| 510k Number | K070108 |
| Device Name: | ELIBRA DYNAMIC KNEE BALANCER |
| Classification | Intraoperative Orthopedic Joint Assessment Aid |
| Applicant | SYNVASIVE TECHNOLOGY, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SYNVASIVE TECHNOLOGY, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | ONN |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-11 |
| Decision Date | 2007-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024355606 | K070108 | 000 |
| 00889024355590 | K070108 | 000 |