Tri-Fix Spinal Fixation System
FDA 510(k) K013403 · Endius, Inc.
510(k) numberK013403
Submission
- Device name
- Tri-Fix Spinal Fixation System
- Applicant
- Endius, Inc.
Plainville, MA, US - Received
- October 15, 2001
- Decision date
- November 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation SystemMNI · Traditional | Mikron Makina Sanayi Ticaret Co. , Ltd. | 10/12/2017SE |
| K160731 | LumFix Spinal Fixation SytemMNI · Traditional | CG Bio Co., Ltd. | 10/04/2016SE |
| K151458 | Double Medical Universal Spine SystemMNI · Traditional | Double Medical Technology, Inc. | 08/22/2016SE |
| K153273 | MySpine Pedicle Screw Placement Guides - LPMNI · Traditional | Medacta International S.A. | 06/29/2016SE |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemMNI · Special | Spinevision S.A. | 04/04/2016SE |
| K160320 | PremierMNI · Traditional | Shandong Weigao Orthopaedic Device Co., Ltd. | 04/01/2016SE |
| K160003 | Sniper (R) Spine SystemMNI · Traditional | Spine Wave, Inc. | 02/26/2016SE |
| K152324 | YAHUA Spinal SystemMNI · Traditional | Beijing Weigao Yahua Artificial Joint… | 02/01/2016SE |
| K143222 | FIREFLY Pedicle Screw Navigation GuideMNI · Traditional | Mighty Oak Medical, Inc. | 12/11/2015SE |
| K150684 | WASTON General Spinal SystemMNI · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 11/18/2015SE |
More from Changzhou Waston Medical Appliance 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 |
| K073267 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 01/30/2008SE |
| 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 |
Questions and answers
When was Tri-Fix Spinal Fixation System cleared by the FDA?
Tri-Fix Spinal Fixation System (K013403) received a 510(k) decision of Substantially Equivalent on November 14, 2001, 30 days after the submission was received.
What is the product code of K013403?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.