The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Memory Metal Staples, Easyclip.
Device ID | K122113 |
510k Number | K122113 |
Device Name: | MEMORY METAL STAPLES, EASYCLIP |
Classification | Staple, Fixation, Bone |
Applicant | STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Estela Celi |
Correspondent | Estela Celi STRYKER CORP. 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 | 2012-07-17 |
Decision Date | 2013-03-12 |
Summary: | summary |