Towerlox Pedicle Screw System
FDA 510(k) K122332 · Captiva Spine
510(k) numberK122332
Submission
- Device name
- Towerlox Pedicle Screw System
- Applicant
- Captiva Spine
Apple Valley, MN, US - Received
- August 2, 2012
- Decision date
- October 16, 2012
- 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 |
|---|---|---|
| K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw SystemNKB · Special | 01/31/2020SE |
| K181229 | TirboLOX-C Cervical IBFDODP · Traditional | 09/19/2018SE |
| K180990 | TirboLOX-L Lumbar IBFDMAX · Traditional | 08/13/2018SE |
| K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw SystemNKB · Traditional | 03/19/2018SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | 03/02/2016SE |
| K151116 | CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | 06/26/2015SE |
| K141332 | Captiva Spine SmartLOX Cervical Plate SystemKWQ · Traditional | 06/11/2015SE |
| K142586 | Captiva Spine FuselOX Cervical IBF SystemODP · Traditional | 05/28/2015SE |
| K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemMNH · Special | 08/08/2013SE |
| K122956 | Fuselox Lumbar Interbody Fusion DeviceMAX · Special | 10/25/2012SE |
Questions and answers
When was Towerlox Pedicle Screw System cleared by the FDA?
Towerlox Pedicle Screw System (K122332) received a 510(k) decision of Substantially Equivalent on October 16, 2012, 75 days after the submission was received.
What is the product code of K122332?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.