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FDA 510(k)

MediRod Pedicle Screw System

K-Number: K242764 · 2024-11-13

ApplicantCmf Medicon Surgical, Inc.
Decision Date2024-11-13
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MediRod Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Cmf Medicon Surgical, Inc.. It received FDA 510(k) clearance on 2024-11-13 under 510(k) number K242764. 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 MediRod Pedicle Screw System?

MediRod Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2024-11-13. The listed applicant is Cmf Medicon Surgical, Inc.. The 510(k) number is K242764.

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

MediRod Pedicle Screw System received FDA 510(k) clearance on 2024-11-13, under 510(k) number K242764.

Who is the listed applicant for MediRod Pedicle Screw System?

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

What is the FDA product code for MediRod Pedicle Screw System?

The FDA product code for MediRod Pedicle Screw System is NKB.

Other records listing Cmf Medicon Surgical, 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.

K241253Medicon Epiplating SystemK212126MediExpand Cervical Expandable VBR SystemK190349MediExpand TL Expandable VBR System

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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