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 |