The following data is part of a premarket notification filed by Depuy Mitek Inc., A Johnson And Johnson Company with the FDA for 6-8mm X 30 Mm Intrafix Peek Tapered Screw 7-9mm X 30mm Intrafix Peek Tapered Screw 8-10mm X 30 Mm Intrafix Peek Tapered.
| Device ID | K122123 |
| 510k Number | K122123 |
| Device Name: | 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Contact | Julie Vafides |
| Correspondent | Julie Vafides DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive 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 | 2012-07-18 |
| Decision Date | 2012-10-02 |
| Summary: | summary |