Biomet Graft Delivery Syringes
FDA 510(k) K140710 · Biomet Spine (Aka Ebi, LLC)
510(k) numberK140710
Submission
- Device name
- Biomet Graft Delivery Syringes
- Applicant
- Biomet Spine (Aka Ebi, LLC)
Parsippany, NJ, US - Received
- March 21, 2014
- Decision date
- September 4, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
Other 510(k)s with product code FMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133518 | Maxan Anterior Cervical Plate SystemKWQ · Traditional | 11/05/2014SE |
| K132373 | Biomet Access SystemPDQ · Traditional | 03/27/2014SE |
| K133746 | Polaris Spinal SystemNKB · Traditional | 03/12/2014SE |
| K131615 | Polaris Spinal SystemOSH · Traditional | 09/04/2013SE |
| K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemNKB · Traditional | 02/25/2013SE |
| K123451 | Polaris Spinal System - Ballista II RodsNKB · Special | 12/03/2012SE |
| K122989 | Biomet Lateral Spacer SystemMAX · Traditional | 10/24/2012SE |
| K122378 | Nextgen Altius Oct SystemKWP · Special | 09/20/2012SE |
| K113593 | Nextgen Altius Oct SystemKWP · Traditional | 04/17/2012SE |
| K110650 | Zyston Arc Interbody SpacerMAX · Traditional | 06/30/2011SE |
Questions and answers
When was Biomet Graft Delivery Syringes cleared by the FDA?
Biomet Graft Delivery Syringes (K140710) received a 510(k) decision of Substantially Equivalent on September 4, 2014, 167 days after the submission was received.
What is the product code of K140710?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.