Endius Minit Posterior Cervical and Upper Thoracic Fixation System
FDA 510(k) K073267 · Endius, Inc.
510(k) numberK073267
Submission
- Device name
- Endius Minit Posterior Cervical and Upper Thoracic Fixation System
- Applicant
- Endius, Inc.
Plainville, MA, US - Received
- November 20, 2007
- Decision date
- January 30, 2008
- 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 |
|---|---|---|
| K080258 | Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 03/10/2008SE |
| K073510 | Endius Title 2 Poly Axial Spinal SystemNKB · Traditional | 02/11/2008SE |
| K072840 | Endius Title 2 Polyaxial Spinal SystemNKB · Traditional | 12/07/2007SE |
| K070282 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 09/06/2007SE |
| K070367 | Endius Title 2 Polyaxial Spinal SystemNKB · Traditional | 04/12/2007SE |
| K061345 | Modification to Endius Atavi SystemHRX · Special | 06/06/2006SE |
| K060990 | Endius Title 2 Poly Axial Spinal SystemNKB · Traditional | 04/26/2006SE |
| K060683 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemKWP · Traditional | 04/18/2006SE |
| K053267 | Endius Atavi SystemHRX · Traditional | 01/13/2006SE |
| K041808 | Endius Title 2 Polyaxial Spinal SystemKWP · Special | 10/01/2004SE |
Questions and answers
When was Endius Minit Posterior Cervical and Upper Thoracic Fixation System cleared by the FDA?
Endius Minit Posterior Cervical and Upper Thoracic Fixation System (K073267) received a 510(k) decision of Substantially Equivalent on January 30, 2008, 71 days after the submission was received.
What is the product code of K073267?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.