Sterispine PS
FDA 510(k) K151921 · Safe Orthopaedics
510(k) numberK151921
Submission
- Device name
- Sterispine PS
- Applicant
- Safe Orthopaedics
Eragny Sur Oise, FR - Received
- July 13, 2015
- Decision date
- October 8, 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 |
|---|---|---|
| K201648 | Sterispine PSNKB · Traditional | 07/30/2020SE |
| K170528 | Sterispine PSNKB · Special | 03/09/2017SE |
| K162531 | Sterispine CCOVE · Traditional | 12/29/2016SE |
| K151747 | Sterispine PSNKB · Traditional | 10/05/2015SE |
| K151756 | Sterispine LC CageMAX · Traditional | 08/21/2015SE |
| K150092 | STERISPINE PS Pedicle ScrewNKB · Special | 02/10/2015SE |
| K140802 | Sterispine PSNKB · Special | 06/04/2014SE |
| K133893 | Sterispine LC CageMAX · Abbreviated | 03/14/2014SE |
| K130632 | Sterispine PS Pedicle ScrewNKB · Special | 05/03/2013SE |
| K122021 | Sterispine LC CageMAX · Abbreviated | 09/20/2012SE |
Questions and answers
When was Sterispine PS cleared by the FDA?
Sterispine PS (K151921) received a 510(k) decision of Substantially Equivalent on October 8, 2015, 87 days after the submission was received.
What is the product code of K151921?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.