Medyssey Cannulated Pedicle Screw
FDA 510(k) K121670 · Medyssey Co, Ltd.
510(k) numberK121670
Submission
- Device name
- Medyssey Cannulated Pedicle Screw
- Applicant
- Medyssey Co, Ltd.
Skokie, IL, US - Received
- June 6, 2012
- Decision date
- January 25, 2013
- 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.
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| 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 |
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| K121320 | C7 Anterior Cervical Intervertebral Fusion CageODP · Traditional | 08/10/2012SE |
| K121246 | Medyssy LT Cage SystemMAX · Special | 06/15/2012SE |
| K110284 | Novel III Spinal Fixation and Adjustable Bridge SystemMNI · Special | 06/08/2011SE |
| K110283 | Zenius Spinal SystemMNI · Special | 05/19/2011SE |
| K110067 | LP CageMAX · Traditional | 04/08/2011SE |
| K103272 | Zenius Spinal SystemMNI · Special | 12/29/2010SE |
| K103147 | Novel III Spinal Fixation and Adjustable Bridge SystemMNI · Special | 12/16/2010SE |
| K093104 | Medyssey Co., Ltd., Zenius Spinal SystemMNI · Traditional | 06/25/2010SE |
Questions and answers
When was Medyssey Cannulated Pedicle Screw cleared by the FDA?
Medyssey Cannulated Pedicle Screw (K121670) received a 510(k) decision of Substantially Equivalent on January 25, 2013, 233 days after the submission was received.
What is the product code of K121670?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.