Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
FDA 510(k) K160020 · Captiva Spine
510(k) numberK160020
Submission
- Device name
- Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
- Applicant
- Captiva Spine
Jupiter, FL, US - Received
- January 5, 2016
- Decision date
- March 2, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | Reliance Medical Systems, LLC | 12/02/2016SE |
| K162801 | CastleLoc Spinal Fixation SystemMNH · Special | L&K BIOMED Co., Ltd. | 11/03/2016SE |
| K162143 | FixxSure® X-LinkMNH · Traditional | Innovasis, Inc. | 09/23/2016SE |
| K161151 | Spinal fixation systemMNH · Traditional | Canwell Medical Co., Ltd. | 09/21/2016SE |
| K162189 | ANAX 5.5 Spinal SystemMNH · Special | U&I Corporation | 08/30/2016SE |
| K151362 | HC Spinal SystemMNH · Traditional | Hung Chun Bio-S Co., Ltd. | 05/05/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | Zavation, LLC | 04/21/2016SE |
| K143013 | Spinal Inner Fixation SystemMNH · Traditional | Changzhou Dingjian Medical Appliance Co., Ltd. | 12/11/2015SE |
| K151695 | Romeo posterior osteosynthesis systemMNH · Traditional | Spineart | 09/10/2015SE |
| K151116 | CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 06/26/2015SE |
More from Captiva Spine
| 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 |
| 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 |
| K122332 | Towerlox Pedicle Screw SystemMNI · Special | 10/16/2012SE |
Questions and answers
When was Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System cleared by the FDA?
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (K160020) received a 510(k) decision of Substantially Equivalent on March 2, 2016, 57 days after the submission was received.
What is the product code of K160020?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.