The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Rigidloop Fixation Device (15mm, 60mm, Xl, 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm, 55mm.
Device ID | K130814 |
510k Number | K130814 |
Device Name: | RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Kristine Christo |
Correspondent | Kristine Christo DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-25 |
Decision Date | 2013-08-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886705022809 | K130814 | 000 |