The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Milagro Advance Interference Screw.
Device ID | K123362 |
510k Number | K123362 |
Device Name: | MILAGRO ADVANCE INTERFERENCE SCREW |
Classification | Screw, Fixation, Bone |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Yayoi Fujimaki |
Correspondent | Yayoi Fujimaki 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 | 2012-11-01 |
Decision Date | 2013-02-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886705023318 | K123362 | 000 |
10886705022267 | K123362 | 000 |
10886705022274 | K123362 | 000 |
10886705022281 | K123362 | 000 |
10886705022298 | K123362 | 000 |
10886705022304 | K123362 | 000 |
10886705022311 | K123362 | 000 |
10886705022328 | K123362 | 000 |
10886705022335 | K123362 | 000 |
10886705023301 | K123362 | 000 |
10886705022236 | K123362 | 000 |