The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Ceboplane.
| Device ID | K933933 |
| 510k Number | K933933 |
| Device Name: | CEBOPLANE |
| Classification | Instrument, Cutting, Orthopedic |
| Applicant | SYNVASIVE TECHNOLOGY, INC. 11328 SUNRISE GOLD CIRCLE Rancho Cordova, CA 95742 |
| Contact | Carol Laufenberg |
| Correspondent | Carol Laufenberg SYNVASIVE TECHNOLOGY, INC. 11328 SUNRISE GOLD CIRCLE Rancho Cordova, CA 95742 |
| Product Code | HTZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-11 |
| Decision Date | 1994-04-15 |