The following data is part of a premarket notification filed by Biomet Spine (aka Ebi, Llc) with the FDA for Biomet Graft Delivery Syringes.
| Device ID | K140710 |
| 510k Number | K140710 |
| Device Name: | BIOMET GRAFT DELIVERY SYRINGES |
| Classification | Syringe, Piston |
| Applicant | BIOMET SPINE (AKA EBI, LLC) 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Debra L Bing |
| Correspondent | Kimberly Mccoy BIOMET SPINE (AKA EBI, LLC) 310 Interlocken Parkway Suit 120 Broomfield, CO 80021 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-21 |
| Decision Date | 2014-09-04 |
| Summary: | summary |