The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Graftmax Button, Alb With Cradle, Graftmax Button, Btb With Cradle.
| Device ID | K151037 |
| 510k Number | K151037 |
| Device Name: | GraftMax Button, ALB With Cradle, GraftMax Button, BTB With Cradle |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CONMED CORPORATION 525 FRENCH ROAD Utica, NY 11502 |
| Contact | Nyrobia Freeman |
| Correspondent | Nyrobia Freeman CONMED CORPORATION 525 FRENCH ROAD Utica, NY 11502 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-07-09 |
| Summary: | summary |