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 |