Preference Elite Pedicle Screw System
FDA 510(k) K162160 · Amedica Corporation
510(k) numberK162160
Submission
- Device name
- Preference Elite Pedicle Screw System
- Applicant
- Amedica Corporation
Slat Lake City, UT, US - Received
- August 2, 2016
- Decision date
- November 18, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
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|---|---|---|---|
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 09/04/2026SE |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional | MANTIZ Co., Ltd. | 07/24/2026SE |
| K253943 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 07/24/2026SE |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 07/14/2026SE |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/01/2026SE |
| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
| K251251 | ChanPin Pedicle Screw Spinal SystemNKB · Traditional | Chanpin Medtak Co., Ltd. | 06/09/2026SE |
| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | L&K BIOMED Co., Ltd. | 05/05/2026SE |
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| K173453 | Valeo® C+CSC with Lumen Interbody Fusion DeviceODP · Traditional | 03/05/2018SE |
| K161405 | Valeo II Interbody Fusion Device SystemMAX · Special | 08/19/2016SE |
| K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device SystemMAX · Traditional | 10/02/2015SE |
| K142264 | Valeo C Spacer System, Valeo II C IBF DeviceODP · Traditional | 12/08/2014SE |
| K142347 | Amedica Valeo II Interbody Fusion DeviceMAX · Traditional | 11/18/2014SE |
| K121892 | Phantom Plus Ceramic Cage SystemMAX · Special | 08/24/2012SE |
| K091278 | Valeo Spacer SystemMAX · Traditional | 01/28/2010SE |
| K082037 | Seeplate Cervical Plate SystemKWQ · Special | 09/26/2008SE |
| K073430 | Valeo Pedicle Screw Spinal SystemNKB · Traditional | 01/29/2008SE |
| K073505 | Modification to Valeo VBRMQP · Special | 01/09/2008SE |
Questions and answers
When was Preference Elite Pedicle Screw System cleared by the FDA?
Preference Elite Pedicle Screw System (K162160) received a 510(k) decision of Substantially Equivalent on November 18, 2016, 108 days after the submission was received.
What is the product code of K162160?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.