The following data is part of a premarket notification filed by Biomaterials Korea Inc. with the FDA for Bone Plate; Bone Screw.
| Device ID | K110926 |
| 510k Number | K110926 |
| Device Name: | BONE PLATE; BONE SCREW |
| Classification | Plate, Bone |
| Applicant | BIOMATERIALS KOREA INC. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls BIOMATERIALS KOREA INC. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-01 |
| Decision Date | 2011-12-08 |