The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Conmed Linvatec Xo Button.
| Device ID | K070780 |
| 510k Number | K070780 |
| Device Name: | CONMED LINVATEC XO BUTTON |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Joy Lovett |
| Correspondent | Joy Lovett CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-21 |
| Decision Date | 2007-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854016302 | K070780 | 000 |
| 10845854042236 | K070780 | 000 |
| 20845854012656 | K070780 | 000 |
| 20845854012663 | K070780 | 000 |
| 20845854015619 | K070780 | 000 |
| 20845854015626 | K070780 | 000 |
| 20845854015633 | K070780 | 000 |
| 20845854015817 | K070780 | 000 |
| 20845854015947 | K070780 | 000 |
| 20845854016050 | K070780 | 000 |
| 20845854016135 | K070780 | 000 |
| 10845854042229 | K070780 | 000 |