Streamline TL Spinal Fixation System
FDA 510(k) K192800 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
510(k) numberK192800
Submission
- Device name
- Streamline TL Spinal Fixation System
- Applicant
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Marquette, MI, US - Received
- September 30, 2019
- Decision date
- January 14, 2020
- 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 |
|---|---|---|
| K201497 | EVOS Cabling SystemJDQ · Traditional | 10/28/2020SE |
| K200513 | DAC Dynamic Active Compression PlateHRS · Traditional | 07/22/2020SE |
| K200095 | Streamline Navigated InstrumentsOLO · Traditional | 06/26/2020SE |
| K193468 | Tritium Sternal Cable Plate SystemJDQ · Traditional | 03/12/2020SE |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyMAX · Traditional | 12/20/2019SE |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs:…MAX · Traditional | 07/05/2019SE |
| K183060 | CervAlign Anterior Cervical Plate SystemKWQ · Traditional | 01/17/2019SE |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic SystemNKG · Traditional | 08/18/2017SE |
| K170830 | Unison-C Anterior Cervical Fixation SystemOVE · Traditional | 06/28/2017SE |
| K161876 | Tritium® Sternal Cable Plate SystemJDQ · Special | 09/09/2016SE |
Questions and answers
When was Streamline TL Spinal Fixation System cleared by the FDA?
Streamline TL Spinal Fixation System (K192800) received a 510(k) decision of Substantially Equivalent on January 14, 2020, 106 days after the submission was received.
What is the product code of K192800?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.