The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809.
| Device ID | K103831 |
| 510k Number | K103831 |
| Device Name: | DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Deep Pal |
| Correspondent | Deep Pal 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 | 2010-12-30 |
| Decision Date | 2011-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705010769 | K103831 | 000 |
| 10886705010721 | K103831 | 000 |
| 10886705010714 | K103831 | 000 |