JASPER Spinal Fixation System
FDA 510(k) K173645 · Gbs Commonwealth Co., Ltd.
510(k) numberK173645
Submission
- Device name
- JASPER Spinal Fixation System
- Applicant
- Gbs Commonwealth Co., Ltd.
Geumcheon-Gu, KR - Received
- November 27, 2017
- Decision date
- July 23, 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 |
|---|---|---|
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…ODP · Special | 12/20/2023SE |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…ODP · Traditional | 11/21/2023SE |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion SystemMAX · Traditional | 11/07/2023SE |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…ODP · Special | 10/13/2023SE |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…ODP · Traditional | 05/22/2023SE |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…ODP · Traditional | 02/17/2023SE |
| K213980 | Peridot Spinal Interbody SystemODP · Traditional | 03/15/2022SE |
| K211205 | Prase-C Anterior Cervical Plate SystemKWQ · Traditional | 08/12/2021SE |
| K202872 | Prase PEEK Anterior Cervical Interbody SpacerODP · Traditional | 02/04/2021SE |
| K202878 | Prase-AP Anterior Cervical Plate SystemKWQ · Traditional | 01/29/2021SE |
Questions and answers
When was JASPER Spinal Fixation System cleared by the FDA?
JASPER Spinal Fixation System (K173645) received a 510(k) decision of Substantially Equivalent on July 23, 2018, 238 days after the submission was received.
What is the product code of K173645?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.