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 |