The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Gryphon Br Anchor W/ Proknot Technology, Gryphon Br Anchor W/ Proknot Technology - Hip, Gryphon Peek Anchor W/ Proknot T.
Device ID | K132241 |
510k Number | K132241 |
Device Name: | GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Yayori Fujimaki |
Correspondent | Yayori Fujimaki DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-18 |
Decision Date | 2013-11-05 |
Summary: | summary |