SEURAT Universal Pedicle Screw System
FDA 510(k) K173185 · Ctl Medical Corporation
510(k) numberK173185
Submission
- Device name
- SEURAT Universal Pedicle Screw System
- Applicant
- Ctl Medical Corporation
Addison, TX, US - Received
- September 29, 2017
- Decision date
- February 14, 2018
- 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 |
|---|---|---|
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage SystemMAX · Traditional | 10/10/2024SE |
| K231715 | MONDRIAN Anterior Lumbar Plate SystemKWQ · Traditional | 01/26/2024SE |
| K231359 | RODIN Expandable Lumbar Cage SystemMAX · Special | 06/09/2023SE |
| K220513 | NITRO Interbody Fusion Cage System FamilyODP · Traditional | 04/25/2023SE |
| K220334 | MONET Anterior Cervical Plate SystemKWQ · Traditional | 11/09/2022SE |
| K211785 | CASSATT SIJ Fixation SystemOUR · Traditional | 10/17/2022SE |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation PlateMAX · Traditional | 09/15/2022SE |
| K213491 | Universal Pilot Guidance Instrument SystemOLO · Traditional | 05/12/2022SE |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage SystemMAX · Traditional | 08/26/2020SE |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation PlateOVE · Traditional | 10/11/2018SE |
Questions and answers
When was SEURAT Universal Pedicle Screw System cleared by the FDA?
SEURAT Universal Pedicle Screw System (K173185) received a 510(k) decision of Substantially Equivalent on February 14, 2018, 138 days after the submission was received.
What is the product code of K173185?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.