M.U.S.T. Extension
FDA 510(k) K141044 · Medacta International
510(k) numberK141044
Submission
- Device name
- M.U.S.T. Extension
- Applicant
- Medacta International
Chicago, IL, US - Received
- April 23, 2014
- Decision date
- August 18, 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.
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 |
|---|---|---|
| K261016 | MSS - Humeral reverse liners extensionPHX · Traditional | 06/10/2026SE |
| K160605 | MectaLIF Anterior Stand-AloneOVD · Traditional | 07/21/2016SE |
| K160289 | MasterLoc StemLZO · Traditional | 05/20/2016SE |
| K153664 | M.U.S.T. Pedicle Screw SystemNKB · Special | 01/19/2016SE |
| K151531 | MasterLoc StemLZO · Traditional | 10/30/2015SE |
| K142744 | Mecta-C TiPEEKODP · Traditional | 05/07/2015SE |
| K143453 | Mpact Double Mobility SystemLPH · Traditional | 03/02/2015SE |
| K142069 | GMK ExtensionJWH · Traditional | 12/02/2014SE |
| K141988 | M.U.S.T Pedicle Screw SystemNKB · Special | 08/19/2014SE |
| K140826 | GMK Sphere ExtensionJWH · Traditional | 07/15/2014SE |
Questions and answers
When was M.U.S.T. Extension cleared by the FDA?
M.U.S.T. Extension (K141044) received a 510(k) decision of Substantially Equivalent on August 18, 2014, 117 days after the submission was received.
What is the product code of K141044?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.