Syntec Os Spinal Fixation System
FDA 510(k) K101971 · Syntec Scientific Corp.
510(k) numberK101971
Submission
- Device name
- Syntec Os Spinal Fixation System
- Applicant
- Syntec Scientific Corp.
Chang Hua, TW - Received
- July 13, 2010
- Decision date
- March 25, 2011
- 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 |
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| K202935 | Syntec Femoral Nail Extended SystemHSB · Special | 10/28/2020SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | 05/05/2020SE |
| K191617 | Syntec Tibial Nail SystemHSB · Traditional | 09/03/2019SE |
| K181296 | Syntec Femoral Nail SystemHSB · Traditional | 04/11/2019SE |
| K161327 | Syntec Humeral Nail SystemHSB · Traditional | 06/08/2017SE |
| K111189 | Syntec Dental ImplantDZE · Traditional | 12/20/2012SE |
| K092889 | Syntec Osteo-Plate and Screw FixationHRS · Traditional | 06/25/2010SE |
| K090476 | Syntec Orthodontic Mini ScrewOAT · Traditional | 06/18/2009SE |
| K090839 | Modification to Syntec-Taichun Non-Sterile Bone Plate and Screw ImplantsHRS · Special | 04/24/2009SE |
Questions and answers
When was Syntec Os Spinal Fixation System cleared by the FDA?
Syntec Os Spinal Fixation System (K101971) received a 510(k) decision of Substantially Equivalent on March 25, 2011, 255 days after the submission was received.
What is the product code of K101971?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.