The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Cais Staple.
Device ID | K073281 |
510k Number | K073281 |
Device Name: | CAIS STAPLE |
Classification | Staple, Fixation, Bone |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Ruth C Forstadt |
Correspondent | Ruth C Forstadt DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-21 |
Decision Date | 2008-05-02 |
Summary: | summary |