The following data is part of a premarket notification filed by Smith & Nephew, Inc with the FDA for Biosure Healicoil Pk Interference Screw.
Device ID | K140879 |
510k Number | K140879 |
Device Name: | BIOSURE HEALICOIL PK INTERFERENCE SCREW |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | Smith & Nephew, Inc 150 MINUTEMAN DR. Andover, MA 01810 |
Contact | Vivek Mukhatyar |
Correspondent | Vivek Mukhatyar Smith & Nephew, Inc 150 MINUTEMAN DR. Andover, MA 01810 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-07 |
Decision Date | 2014-07-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00885556541234 | K140879 | 000 |
00885556541197 | K140879 | 000 |
00885556541173 | K140879 | 000 |
00885556541142 | K140879 | 000 |