Xia Spinal System, Stainless Steel Uni-Planar Screws
FDA 510(k) K080928 · Stryker Spine
510(k) numberK080928
Submission
- Device name
- Xia Spinal System, Stainless Steel Uni-Planar Screws
- Applicant
- Stryker Spine
Allendale, NJ, US - Received
- April 2, 2008
- Decision date
- April 30, 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 |
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| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | 07/17/2026SE |
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| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…KWQ · Traditional | 11/07/2024SE |
| K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…MQV · Special | 08/29/2024SE |
| K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…NKB · Traditional | 06/08/2023SE |
| K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…ODP · Traditional | 02/14/2023SE |
| K203205 | Navigated Spine InstrumentsOLO · Traditional | 03/23/2021SE |
| K200666 | Stryker Xia 3 Power AdaptorNKB · Special | 04/23/2020SE |
| K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…MAX · Traditional | 07/25/2019SE |
| K183071 | VLIFT-s Vertebral Body Replacement SystemPLR · Special | 01/10/2019SE |
Questions and answers
When was Xia Spinal System, Stainless Steel Uni-Planar Screws cleared by the FDA?
Xia Spinal System, Stainless Steel Uni-Planar Screws (K080928) received a 510(k) decision of Substantially Equivalent on April 30, 2008, 28 days after the submission was received.
What is the product code of K080928?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.