The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Bioknotless Rc Anchor.
Device ID | K041064 |
510k Number | K041064 |
Device Name: | BIOKNOTLESS RC ANCHOR |
Classification | Staple, Fixation, Bone |
Applicant | Depuy Mitek 249 VANDERBILT DR. Norwood, MA 02062 |
Contact | Allyson Barford |
Correspondent | Allyson Barford Depuy Mitek 249 VANDERBILT DR. Norwood, MA 02062 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-23 |
Decision Date | 2004-05-13 |
Summary: | summary |