The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Spinalplane.
Device ID | K934336 |
510k Number | K934336 |
Device Name: | SPINALPLANE |
Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
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 | HSZ |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-07 |
Decision Date | 1995-03-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SPINALPLANE 74319645 not registered Dead/Abandoned |
SYNVASIVE TECHNOLOGIES, INC. 1992-10-01 |