RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System
FDA 510(k) K193100 · OrthoPediatrics Corp.
510(k) numberK193100
Submission
- Device name
- RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System
- Applicant
- OrthoPediatrics Corp.
Warsaw, IN, US - Received
- November 8, 2019
- Decision date
- March 24, 2020
- 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 |
|---|---|---|
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate SystemHRS · Traditional | 04/30/2026SE |
| K252600 | Pediatric Plating Platform I Small-MiniHRS · Traditional | 10/09/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | 06/24/2025SE |
| K243963 | Pediatric Plating Platform HipHRS · Traditional | 04/29/2025SE |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurHSB · Special | 04/01/2025SE |
| K241816 | VerteGlide Spinal Growth Guidance SystemPGM · Traditional | 03/14/2025SE |
| K243798 | Orthex External Fixation SystemKTT · Traditional | 03/07/2025SE |
| K233105 | RESPONSE Rib and Pelvic SystemMDI · Traditional | 01/20/2024SE |
| K231266 | Pediatric Nailing Platform TibiaHSB · Traditional | 08/21/2023SE |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw SystemNKB · Special | 03/23/2023SE |
Questions and answers
When was RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System cleared by the FDA?
RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System (K193100) received a 510(k) decision of Substantially Equivalent on March 24, 2020, 137 days after the submission was received.
What is the product code of K193100?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.