The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Rigidfix Biocryl 2.7mm Btb (210815), Femoral 3.3mm St (210816), And Tibial 3.3mm St (210817) Cross Pin Kits.
Device ID | K091041 |
510k Number | K091041 |
Device Name: | RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Zheng Liu |
Correspondent | Zheng Liu DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | MAI |
Subsequent Product Code | HTY |
Subsequent Product Code | HWC |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-13 |
Decision Date | 2009-08-07 |
Summary: | summary |