Expedium 4.5MM Spine System
FDA 510(k) K073364 · Depuy Spine, Inc.
510(k) numberK073364
Submission
- Device name
- Expedium 4.5MM Spine System
- Applicant
- Depuy Spine, Inc.
Raynham, MA, US - Received
- November 30, 2007
- Decision date
- April 4, 2008
- 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.
Other 510(k)s with product code NKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 09/04/2026SE |
| 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 |
|---|---|---|
| K222276 | CONDUIT Cages; FIBERGRAFT BG PuttyODP · Traditional | 10/15/2022SE |
| K201831 | CONFIDENCE Spinal Cement SystemNDN · Traditional | 08/31/2020SE |
| K142185 | Expedium Verse Spine SystemNKB · Traditional | 11/19/2014SE |
| K111136 | Expedium Spine System, Viper System, Viper 2 SystemNKB · Traditional | 06/14/2012SESU |
| K121020 | Viper SystemNKB · Special | 05/03/2012SE |
| K110353 | Mountaineer Oct Spinal SystemKWP · Special | 04/07/2011SE |
| K110216 | Expedium System, Viper SystemNKB · Special | 04/01/2011SE |
| K103133 | Veper System, Expedium SystemNKB · Special | 01/18/2011SE |
| K101993 | Viper System, Expedium SystemNKB · Special | 12/07/2010SE |
| K101923 | Concorde Curve SystemMAX · Special | 12/01/2010SE |
Questions and answers
When was Expedium 4.5MM Spine System cleared by the FDA?
Expedium 4.5MM Spine System (K073364) received a 510(k) decision of Substantially Equivalent on April 4, 2008, 126 days after the submission was received.
What is the product code of K073364?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.