Modification to Vertebron PSS Pedicle Screw System
FDA 510(k) K081597 · Vertebron, Inc.
510(k) numberK081597
Submission
- Device name
- Modification to Vertebron PSS Pedicle Screw System
- Applicant
- Vertebron, Inc.
Stratford, CT, US - Received
- June 6, 2008
- Decision date
- July 2, 2008
- 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 |
|---|---|---|
| K081567 | Vertebron SSP Cervical Plating SystemKWQ · Special | 07/03/2008SE |
| K073502 | Vertebron VBR SystemMQP · Traditional | 03/24/2008SE |
| K071376 | Modification to Vertebron PSS Pedicle Screw SystemNKB · Special | 06/13/2007SE |
| K062110 | Vertebron SCP Cervical Plate SystemKWQ · Special | 08/16/2006SE |
| K051815 | Modification to Vertebron SCP Cervical Plate SystemKWQ · Special | 10/17/2005SE |
| K051716 | Vertebron PSS Pedicle Screw SystemKWP · Special | 09/07/2005SE |
| K043152 | Vertebron PSS Pedicle Screw SystemMNH · Special | 02/01/2005SE |
| K043181 | Modification to Vertebron SCP Cervical Plate SystemKWQ · Special | 12/17/2004SE |
| K040003 | Vertebron SCP Cervical Plate SystemKWQ · Traditional | 03/26/2004SE |
| K033352 | Vertebron PSS Pedicle Screw SystemMNI · Traditional | 02/25/2004SE |
Questions and answers
When was Modification to Vertebron PSS Pedicle Screw System cleared by the FDA?
Modification to Vertebron PSS Pedicle Screw System (K081597) received a 510(k) decision of Substantially Equivalent on July 2, 2008, 26 days after the submission was received.
What is the product code of K081597?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.