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 |
| 10886705022663 | K130814 | 000 |
| 10886705022670 | K130814 | 000 |
| 10886705022687 | K130814 | 000 |
| 10886705022694 | K130814 | 000 |
| 10886705022700 | K130814 | 000 |
| 10886705022717 | K130814 | 000 |
| 10886705022724 | K130814 | 000 |
| 10886705022731 | K130814 | 000 |
| 10886705022656 | K130814 | 000 |