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FDA 510(k)

Preference Elite Pedicle Screw System

K-Number: K162160 · 2016-11-18

ApplicantAmedica Corporation
Decision Date2016-11-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Preference Elite Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Amedica Corporation. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K162160. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Preference Elite Pedicle Screw System?

Preference Elite Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Amedica Corporation. The 510(k) number is K162160.

When did Preference Elite Pedicle Screw System receive FDA 510(k) clearance?

Preference Elite Pedicle Screw System received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162160.

Who is the listed applicant for Preference Elite Pedicle Screw System?

The FDA 510(k) record lists Amedica Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Preference Elite Pedicle Screw System?

The FDA product code for Preference Elite Pedicle Screw System is NKB.

Other records listing Amedica Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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