InFill Graft Delivery System
FDA 510(k) K143488 · Pinnacle Spine Group, LLC
510(k) numberK143488
Submission
- Device name
- InFill Graft Delivery System
- Applicant
- Pinnacle Spine Group, LLC
Dallas, TX, US - Received
- December 8, 2014
- Decision date
- December 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K172349 | InFill® Interbody Fusion DeviceMAX · Traditional | 12/14/2017SE |
| K152259 | InFill Interbody Fusion DeviceMAX · Traditional | 11/19/2015SE |
| K151184 | InFill Interbody Fusion DevicesMAX · Traditional | 07/14/2015SE |
| K150206 | InFill Interbody Fusion DevicesMAX · Special | 04/03/2015SE |
| K141282 | PGS 5.5 MM Cannulated Pedicle ScrewNKB · Traditional | 12/02/2014SE |
| K140066 | Infill CervicalODP · Traditional | 05/05/2014SE |
| K133721 | Infill 41-TLIF Convex Oblique Device, Infill 43-TLIF Contour Oblique, Infill 44-TLIF…MAX · Traditional | 03/31/2014SE |
| K124012 | Infill Oblique Tlif DeviceMAX · Traditional | 06/04/2013SE |
| K121476 | Infill Graft Delivery SystemFMF · Special | 08/29/2012SE |
| K121733 | Infill Intervertebral Body Fusion DeviceMAX · Special | 07/13/2012SE |
Questions and answers
When was InFill Graft Delivery System cleared by the FDA?
InFill Graft Delivery System (K143488) received a 510(k) decision of Substantially Equivalent on December 17, 2014, 9 days after the submission was received.
What is the product code of K143488?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.