Vitality Spinal Fixation System
FDA 510(k) K150896 · Zimmer Spine, Inc.
510(k) numberK150896
Submission
- Device name
- Vitality Spinal Fixation System
- Applicant
- Zimmer Spine, Inc.
Minneapolis, MN, US - Received
- April 2, 2015
- Decision date
- August 31, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K153631 | Zimmer Virage OCT Spinal Fixation SystemNKG · Special | 02/16/2016SE |
| K151031 | Virage OCT Spinal Fixation SystemNKG · Traditional | 06/24/2015SE |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…NKB · Traditional | 06/18/2015SE |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…KWQ · Traditional | 03/20/2015SE |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…MAX · Traditional | 02/12/2015SE |
| K142053 | Universal Clamp Spinal Fixation SystemOWI · Traditional | 10/29/2014SE |
| K141500 | Optio-C Anterior Cervical SystemKWQ · Traditional | 09/23/2014SE |
| K133556 | Virage Oct Spinal Fixation SystemKWP · Traditional | 06/02/2014SE |
| K140611 | Trinica Anterior Lumbar Plate SystemKWQ · Traditional | 05/21/2014SE |
| K133184 | Ardis Interbody SystemMAX · Traditional | 01/30/2014SE |
Questions and answers
When was Vitality Spinal Fixation System cleared by the FDA?
Vitality Spinal Fixation System (K150896) received a 510(k) decision of Substantially Equivalent on August 31, 2015, 151 days after the submission was received.
What is the product code of K150896?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.