Zavation Spinal System
FDA 510(k) K112484 · Zavation, LLC
510(k) numberK112484
Submission
- Device name
- Zavation Spinal System
- Applicant
- Zavation, LLC
Brandon, MS, US - Received
- August 29, 2011
- Decision date
- November 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| 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 |
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| K153404 | Zavation Spinal SystemMNH · Traditional | 04/21/2016SE |
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| K142392 | Zavation Posterior LEIFMAX · Traditional | 04/29/2015SE |
| K142271 | Zavation Z-Link LumbarOVD · Traditional | 12/19/2014SE |
| K141419 | ZvplastyNDN · Traditional | 09/12/2014SE |
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Questions and answers
When was Zavation Spinal System cleared by the FDA?
Zavation Spinal System (K112484) received a 510(k) decision of Substantially Equivalent on November 22, 2011, 85 days after the submission was received.
What is the product code of K112484?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.