The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Easystep.
Device ID | K160813 |
510k Number | K160813 |
Device Name: | EasyStep |
Classification | Staple, Fixation, Bone |
Applicant | STRYKER GMBH 325 CORPORATE DRIVE Mahwah, NJ 07430 |
Contact | Garry T. Hayeck |
Correspondent | Garry T. Hayeck STRYKER GMBH 325 CORPORATE DRIVE Mahwah, NJ 07430 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-24 |
Decision Date | 2016-07-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327170726 | K160813 | 000 |
07613327135244 | K160813 | 000 |
07613327135237 | K160813 | 000 |
07613327135220 | K160813 | 000 |
07613327135213 | K160813 | 000 |
07613327135190 | K160813 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EASYSTEP 86966245 5287176 Live/Registered |
Stryker European Holdings I, LLC 2016-04-06 |
EASYSTEP 86542774 5728061 Live/Registered |
McGregor Industries, Inc. 2015-02-23 |
EASYSTEP 85725800 not registered Dead/Abandoned |
MEMOMETAL TECHNOLOGIES, a Société par Actions Simplifiée of France 2012-09-11 |
EASYSTEP 77180596 3474738 Dead/Cancelled |
Brady Worldwide, Inc. 2007-05-14 |
EASYSTEP 76362772 not registered Dead/Abandoned |
Sam Joo Shoes Co., Ltd. 2002-01-25 |
EASYSTEP 75181232 not registered Dead/Abandoned |
Kendall Company, The 1996-10-15 |
EASYSTEP 75149508 2131979 Dead/Cancelled |
Siemens Aktiengesellschaft 1996-08-13 |
EASYSTEP 74318223 1839885 Live/Registered |
INTUIT INC. 1992-09-28 |
EASYSTEP 74309221 1800450 Dead/Cancelled |
VARITRONICS SYSTEMS, INC. 1992-08-27 |