The following data is part of a premarket notification filed by Smith And Nephew, Inc. with the FDA for Double Endobutton Fixation Device.
| Device ID | K183232 |
| 510k Number | K183232 |
| Device Name: | Double ENDOBUTTON Fixation Device |
| Classification | Washer, Bolt Nut |
| Applicant | Smith And Nephew, Inc. 150 Minuteman Road Andover, MA 01810 |
| Contact | Dharaben Desai |
| Correspondent | Dharaben Desai Smith And Nephew, Inc. 150 Minuteman Road Andover, MA 01810 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2019-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556486191 | K183232 | 000 |
| 00885556486146 | K183232 | 000 |
| 00885556467640 | K183232 | 000 |
| 00885556424544 | K183232 | 000 |