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FDA 510(k)

OsteoCentric Spine MIS Pedicle Fastener System

K-Number: K221332 · 2022-07-28

ApplicantOsteoCentric Technologies
Decision Date2022-07-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoCentric Spine MIS Pedicle Fastener System is a medical device manufactured by OsteoCentric Technologies. It received FDA 510(k) clearance on 2022-07-28 under approval number K221332. 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 OsteoCentric Spine MIS Pedicle Fastener System?

OsteoCentric Spine MIS Pedicle Fastener System is a medical device that received FDA 510(k) clearance on 2022-07-28. It is manufactured by OsteoCentric Technologies. The 510(k) number is K221332.

When was OsteoCentric Spine MIS Pedicle Fastener System approved by the FDA?

OsteoCentric Spine MIS Pedicle Fastener System received FDA 510(k) clearance on 2022-07-28, under approval number K221332.

What company makes OsteoCentric Spine MIS Pedicle Fastener System?

OsteoCentric Spine MIS Pedicle Fastener System is manufactured by OsteoCentric Technologies.

What is the FDA product code for OsteoCentric Spine MIS Pedicle Fastener System?

The FDA product code for OsteoCentric Spine MIS Pedicle Fastener System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07574632 A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis. NOT_YET_RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by OsteoCentric Technologies

K211290Cannulated Fasteners and Nuts K210754Cannulated Fasteners and Nuts K222512Integrity-SI Fusion System K230242OsteoCentric Dental Implant System K230226Integrity-SI® Fusion System K230595OsteoCentric ACL Fixation System

View all 11 devices →

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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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