The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Arthroplane.
| Device ID | K932869 |
| 510k Number | K932869 |
| Device Name: | ARTHROPLANE |
| Classification | Arthroscope |
| Applicant | SYNVASIVE TECHNOLOGY, INC. 11328 SUNRISE GOLD CIRCLE Rancho Cordova, CA 95742 |
| Contact | Carol Laufenburg |
| Correspondent | Carol Laufenburg SYNVASIVE TECHNOLOGY, INC. 11328 SUNRISE GOLD CIRCLE Rancho Cordova, CA 95742 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-14 |
| Decision Date | 1994-03-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ARTHROPLANE 74309883 not registered Dead/Abandoned |
Sierra Surgical, Inc. 1992-08-28 |