The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Healix Knotless(tm) Anchor.
Device ID | K112249 |
510k Number | K112249 |
Device Name: | HEALIX KNOTLESS(TM) ANCHOR |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Deep Pal |
Correspondent | Deep Pal DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-05 |
Decision Date | 2011-10-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886705020386 | K112249 | 000 |