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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 the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2022-07-28 under 510(k) 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. The listed applicant is OsteoCentric Technologies. The 510(k) number is K221332.

When did OsteoCentric Spine MIS Pedicle Fastener System receive FDA 510(k) clearance?

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

Who is the listed applicant for OsteoCentric Spine MIS Pedicle Fastener System?

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

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.

Other records listing OsteoCentric Technologies 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.

K250520OsteoCentric Navigated Instruments SystemK251913OsteoCentric® UnifiMI® TCS Plating SystemK250494The OsteoCentric Bone Plate and Screw SystemK242691OsteoCentric Technologies Cannulated Fasteners and NutsK230242OsteoCentric Dental Implant SystemK230226Integrity-SI® Fusion System

View all 12 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.

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