Expedium Spine System
FDA 510(k) K110551 · Johnson & Johnson
510(k) numberK110551
Submission
- Device name
- Expedium Spine System
- Applicant
- Johnson & Johnson
Raynham, MA, US - Received
- February 28, 2011
- Decision date
- October 26, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
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| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional | MANTIZ Co., Ltd. | 07/24/2026SE |
| K253943 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 07/24/2026SE |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 07/14/2026SE |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/01/2026SE |
| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
| K251251 | ChanPin Pedicle Screw Spinal SystemNKB · Traditional | Chanpin Medtak Co., Ltd. | 06/09/2026SE |
| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | L&K BIOMED Co., Ltd. | 05/05/2026SE |
More from L&K BIOMED Co., Ltd.
| 510(k) | Device | Decision |
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| K113348 | Cougar SystemMAX · Special | 12/13/2011SE |
| K110694 | Concorde Bullet Spinal SystemMAX · Special | 10/11/2011SE |
| K111571 | Viper SystemsNKB · Special | 07/06/2011SE |
| K110454 | Cougar LS Lateral Cage SystemMAX · Special | 05/13/2011SE |
| K103743 | Concorde Curve SystemMAX · Special | 03/17/2011SE |
| K103490 | Expedium Spine System, Moss Miami Spine SystemNKB · Traditional | 02/17/2011SE |
| K063577 | Femoral Intrafix Screw and SheathMBI · Traditional | 01/25/2007SE |
| K060914 | Trident AnchorHWC · Traditional | 06/09/2006SE |
Questions and answers
When was Expedium Spine System cleared by the FDA?
Expedium Spine System (K110551) received a 510(k) decision of Substantially Equivalent on October 26, 2011, 240 days after the submission was received.
What is the product code of K110551?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.