The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Milagro Interference Screws.
| Device ID | K120589 |
| 510k Number | K120589 |
| Device Name: | MILAGRO INTERFERENCE SCREWS |
| 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 | 2012-02-28 |
| Decision Date | 2012-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705022250 | K120589 | 000 |
| 10886705022243 | K120589 | 000 |
| 10886705021963 | K120589 | 000 |
| 10886705021956 | K120589 | 000 |
| 10886705020423 | K120589 | 000 |
| 10886705020416 | K120589 | 000 |