K2M Modular Hooks
FDA 510(k) K133402 · K2m, Inc.
510(k) numberK133402
Submission
- Device name
- K2M Modular Hooks
- Applicant
- K2m, Inc.
Chesterland, OH, US - Received
- November 6, 2013
- Decision date
- July 30, 2014
- 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.
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| 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 |
|---|---|---|
| K260546 | Q Pedicle InstrumentsOLO · Special | 03/17/2026SE |
| K253545 | Vulcan Spinal SystemNKB · Traditional | 02/10/2026SE |
| K252873 | Q Interbody InstrumentsOLO · Traditional | 02/06/2026SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | 02/24/2022SE |
| K202528 | Cannulated Power Driver AttachmentNKB · Traditional | 10/26/2020SE |
| K201006 | K2M Navigation InstrumentsOLO · Special | 08/07/2020SE |
| K193203 | MOJAVE Expandable Interbody SystemMAX · Special | 02/18/2020SE |
| K193129 | Yukon OCT Spinal SystemNKG · Traditional | 02/07/2020SE |
| K192911 | Brainlab Compatible K2M Navigation InstrumentsOLO · Special | 11/14/2019SE |
| K190179 | SAHARA Stabilization SystemOVD · Traditional | 10/03/2019SE |
Questions and answers
When was K2M Modular Hooks cleared by the FDA?
K2M Modular Hooks (K133402) received a 510(k) decision of Substantially Equivalent on July 30, 2014, 266 days after the submission was received.
What is the product code of K133402?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.