The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Milagro Interference Screw.
Device ID | K060830 |
510k Number | K060830 |
Device Name: | MILAGRO INTERFERENCE SCREW |
Classification | Screw, Fixation, Bone |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Ruth Forstadt |
Correspondent | Ruth Forstadt DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-27 |
Decision Date | 2006-06-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886705010684 | K060830 | 000 |