The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for 4mm & 5mm Full Radius Blade Plus, 4mm & 5mm Barrel Bur Plus/4mm Barrel Tornado Bur Plus, 4mm & 5mm Aggressive Blade Plus.
| Device ID | K131191 |
| 510k Number | K131191 |
| Device Name: | 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS |
| Classification | Arthroscope |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Susan Kagan |
| Correspondent | Susan Kagan DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-26 |
| Decision Date | 2013-07-22 |
| Summary: | summary |