Pisces Spinal System
FDA 510(k) K203023 · Ortho Development Corporation
510(k) numberK203023
Submission
- Device name
- Pisces Spinal System
- Applicant
- Ortho Development Corporation
Draper, UT, US - Received
- October 2, 2020
- Decision date
- July 14, 2021
- 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.
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|---|---|---|
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | 12/19/2025SE |
| K251052 | Trivicta® Hip StemMEH · Traditional | 05/22/2025SE |
| K242984 | BKS Revision SystemJWH · Special | 10/25/2024SE |
| K242833 | Legend® Acetabular ShellLPH · Special | 10/11/2024SE |
| K233758 | Trivicta Hip StemMEH · Traditional | 03/08/2024SE |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial InsertJWH · Special | 10/25/2023SE |
| K211086 | The Progen Trochanteric Nail SystemHSB · Traditional | 12/21/2021SE |
| K211471 | Balanced Knee System UniHSX · Traditional | 12/16/2021SE |
| K200281 | The Gecko Spinal SystemOWI · Traditional | 03/31/2020SE |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone AugmentsJWH · Traditional | 10/31/2018SE |
Questions and answers
When was Pisces Spinal System cleared by the FDA?
Pisces Spinal System (K203023) received a 510(k) decision of Substantially Equivalent on July 14, 2021, 285 days after the submission was received.
What is the product code of K203023?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.