Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Palisade Pedicular Fixation System

K-Number: K153323 · 2016-02-23

ApplicantSpineology, Inc.
Decision Date2016-02-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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 2016-02-23 under 510(k) number K153323. 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 Palisade Pedicular Fixation System?

Palisade Pedicular Fixation System is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Spineology, Inc.. The 510(k) number is K153323.

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

Palisade Pedicular Fixation System received FDA 510(k) clearance on 2016-02-23, under 510(k) number K153323.

Who is the listed applicant for 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 Palisade Pedicular Fixation System?

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

Other records listing Spineology, Inc. 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.

K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemK251943Spineology Navigation InstrumentsK230927OptiMesh Multiplanar Expandable Interbody Fusion SystemK231781OptiMesh Multiplanar Expandable Interbody Fusion SystemK213876Spineology Navigation InstrumentsK210155Duo Expandable Interbody Fusion System

View all 32 devices →

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.

↑