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FDA 510(k)

MEDYSSEY CANNULATED PEDICLE SCREW

K-Number: K121670 · 2013-01-25

ApplicantMedyssey Co, Ltd.
Decision Date2013-01-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEDYSSEY CANNULATED PEDICLE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey Co, Ltd.. It received FDA 510(k) clearance on 2013-01-25 under 510(k) number K121670. 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 MEDYSSEY CANNULATED PEDICLE SCREW?

MEDYSSEY CANNULATED PEDICLE SCREW is a medical device that received FDA 510(k) clearance on 2013-01-25. The listed applicant is Medyssey Co, Ltd.. The 510(k) number is K121670.

When did MEDYSSEY CANNULATED PEDICLE SCREW receive FDA 510(k) clearance?

MEDYSSEY CANNULATED PEDICLE SCREW received FDA 510(k) clearance on 2013-01-25, under 510(k) number K121670.

Who is the listed applicant for MEDYSSEY CANNULATED PEDICLE SCREW?

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

What is the FDA product code for MEDYSSEY CANNULATED PEDICLE SCREW?

The FDA product code for MEDYSSEY CANNULATED PEDICLE SCREW is NKB.

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Other records listing Medyssey Co, Ltd. as applicant

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K260036NeckTune™ 3D SA Cervical CageK242806Medyssey Navigation SystemK121320C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGEK121246MEDYSSY LT CAGE SYSTEMK110284NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEMK110283ZENIUS SPINAL SYSTEM

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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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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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