True Tulip System, True M.I.S. System
FDA 510(k) K201780 · Innovative Surgical Designs, Inc.
510(k) numberK201780
Submission
- Device name
- True Tulip System, True M.I.S. System
- Applicant
- Innovative Surgical Designs, Inc.
Bloomington, IN, US - Received
- June 30, 2020
- Decision date
- July 22, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K220297 | True Tulip, True M.I.S.NKB · Traditional | 09/16/2022SE |
| K212627 | True Tulip, True M.I.S.NKB · Special | 02/18/2022SE |
| K210816 | True Tulip, True M.I.S.NKB · Special | 05/18/2021SE |
| K181584 | Redi-SpineNKB · Traditional | 08/10/2018SE |
| K171559 | True Spinal Fixation SystemNKB · Traditional | 07/24/2017SE |
| K170710 | True Spinal Fixation SystemNKB · Traditional | 07/14/2017SE |
| K133690 | True Spinal Fussion SystemMNH · Traditional | 05/07/2014SE |
| K130958 | True Spinal Fixation SystemMNI · Traditional | 10/17/2013SE |
Questions and answers
When was True Tulip System, True M.I.S. System cleared by the FDA?
True Tulip System, True M.I.S. System (K201780) received a 510(k) decision of Substantially Equivalent on July 22, 2020, 22 days after the submission was received.
What is the product code of K201780?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.