SPINALPLANE
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
SYNVASIVE TECHNOLOGY, INC.
The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Spinalplane.
Pre-market Notification Details
| 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 |
Trademark Results [SPINALPLANE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPINALPLANE 74319645 not registered Dead/Abandoned |
SYNVASIVE TECHNOLOGIES, INC. 1992-10-01 |
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