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FDA 510(k)

Threshold Pedicular Fixation System, Palisade Pedicular Fixation System

K-Number: K160980 · 2016-05-26

ApplicantSpineology, Inc.
Decision Date2016-05-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Threshold Pedicular Fixation System, Palisade Pedicular Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K160980. 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 Threshold Pedicular Fixation System, Palisade Pedicular Fixation System?

Threshold Pedicular Fixation System, Palisade Pedicular Fixation System is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Spineology, Inc.. The 510(k) number is K160980.

When did Threshold Pedicular Fixation System, Palisade Pedicular Fixation System receive FDA 510(k) clearance?

Threshold Pedicular Fixation System, Palisade Pedicular Fixation System received FDA 510(k) clearance on 2016-05-26, under 510(k) number K160980.

Who is the listed applicant for Threshold Pedicular Fixation System, Palisade Pedicular Fixation System?

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

What is the FDA product code for Threshold Pedicular Fixation System, Palisade Pedicular Fixation System?

The FDA product code for Threshold Pedicular Fixation System, Palisade Pedicular Fixation System is NKB.

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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

View on FDA Database →

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

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