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 |