The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Synvasive Ceramic Sutting Block.
| Device ID | K930573 |
| 510k Number | K930573 |
| Device Name: | SYNVASIVE CERAMIC SUTTING BLOCK |
| Classification | Guide, Drill, Ligament |
| Applicant | SYNVASIVE TECHNOLOGY, INC. 11328 SUNRISE GOLD CIRCLE Rancho Cordova, CA 95742 |
| Contact | Keith L Mullowney |
| Correspondent | Keith L Mullowney SYNVASIVE TECHNOLOGY, INC. 11328 SUNRISE GOLD CIRCLE Rancho Cordova, CA 95742 |
| Product Code | LXI |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-04 |
| Decision Date | 1994-04-07 |