PASS LP Spinal System, CD Horizon Spinal System
FDA 510(k) K213281 · Medicrea International SA
510(k) numberK213281
Submission
- Device name
- PASS LP Spinal System, CD Horizon Spinal System
- Applicant
- Medicrea International SA
Rillieux-La-Pape, FR - Received
- October 1, 2021
- Decision date
- January 5, 2022
- 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 |
|---|---|---|
| K213659 | LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional | 05/24/2022SE |
| K220810 | Infinity OCT System and PASS OCT Spinal SystemNKG · Special | 04/19/2022SE |
| K220724 | CD Horizon Spinal System and PASS LP Spinal SystemNKB · Special | 04/08/2022SE |
| K212005 | UNiD Spine AnalyzerLLZ · Traditional | 01/12/2022SE |
| K210470 | C-CURVE Interbody Fusion DeviceOVE · Traditional | 09/03/2021SE |
| K200316 | UNiD IB3D ALIFMAX · Traditional | 10/30/2020SE |
| K191134 | IB3D AlifMAX · Traditional | 10/30/2019SE |
| K182158 | UNiD Patient-matched PLIF cageMAX · Traditional | 07/15/2019SE |
| K190092 | UNiD Patient specific 3D printed TLIF cageMAX · Traditional | 05/08/2019SE |
| K190376 | PASS LP Spinal SystemNKB · Traditional | 05/02/2019SE |
Questions and answers
When was PASS LP Spinal System, CD Horizon Spinal System cleared by the FDA?
PASS LP Spinal System, CD Horizon Spinal System (K213281) received a 510(k) decision of Substantially Equivalent on January 5, 2022, 96 days after the submission was received.
What is the product code of K213281?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.