MILAGRO ADVANCE INTERFERENCE SCREW

Screw, Fixation, Bone

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

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.

Pre-market Notification Details

Device IDK123362
510k NumberK123362
Device Name:MILAGRO ADVANCE INTERFERENCE SCREW
ClassificationScrew, Fixation, Bone
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
ContactYayoi Fujimaki
CorrespondentYayoi Fujimaki
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-01
Decision Date2013-02-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.