Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
FDA 510(k) K240872 · Clariance
510(k) numberK240872
Submission
- Device name
- Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
- Applicant
- Clariance
Beaurains, FR - Received
- March 29, 2024
- Decision date
- April 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K243904 | Elegance® Anterior Cervical plateKWQ · Special | 01/14/2025SE |
| K243670 | Idys® LIFMAX · Special | 12/31/2024SE |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MISNKB · Special | 07/24/2024SE |
| K240715 | Idys® C ZP 3DTiOVE · Special | 03/22/2024SE |
| K220182 | Aggeris-CKWQ · Traditional | 03/30/2022SE |
| K212562 | Idys-C ZP 3DTiOVE · Traditional | 10/12/2021SE |
| K200919 | Idys ALIF 3DTiMAX · Traditional | 04/12/2021SE |
| K202032 | Idys LLIF 3DTiOVD · Traditional | 04/01/2021SE |
| K202956 | Erisma LP Navigated InstrumentsOLO · Traditional | 02/26/2021SE |
| K200920 | Idys ALIF ZP 3DTiMAX · Special | 05/29/2020SE |
Questions and answers
When was Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System cleared by the FDA?
Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (K240872) received a 510(k) decision of Substantially Equivalent on April 26, 2024, 28 days after the submission was received.
What is the product code of K240872?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.