Zavation Spinal System
FDA 510(k) K153404 · Zavation, LLC
510(k) numberK153404
Submission
- Device name
- Zavation Spinal System
- Applicant
- Zavation, LLC
Flowood, MS, US - Received
- November 24, 2015
- Decision date
- April 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 03/02/2016SE |
| 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 |
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| K162824 | Z-Span Plate SystemKWQ · Traditional | 02/17/2017SE |
| K161016 | Z-Clamp ISP SystemPEK · Traditional | 10/19/2016SE |
| K160362 | Z-Span Plate SystemKWQ · Traditional | 03/22/2016SE |
| K142392 | Zavation Posterior LEIFMAX · Traditional | 04/29/2015SE |
| K142271 | Zavation Z-Link LumbarOVD · Traditional | 12/19/2014SE |
| K141419 | ZvplastyNDN · Traditional | 09/12/2014SE |
| K141005 | Z-Link CervicalOVE · Traditional | 08/07/2014SE |
| K130030 | Zavation Cervical Plate SystemKWQ · Traditional | 04/25/2013SE |
Questions and answers
When was Zavation Spinal System cleared by the FDA?
Zavation Spinal System (K153404) received a 510(k) decision of Substantially Equivalent on April 21, 2016, 149 days after the submission was received.
What is the product code of K153404?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.