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FDA 510(k)

CosmoLock Pedicle Screw System

K-Number: K172808 · 2017-10-25

ApplicantKalitec Direct, LLC
Decision Date2017-10-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CosmoLock Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Direct, LLC. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K172808. 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 CosmoLock Pedicle Screw System?

CosmoLock Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Kalitec Direct, LLC. The 510(k) number is K172808.

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

CosmoLock Pedicle Screw System received FDA 510(k) clearance on 2017-10-25, under 510(k) number K172808.

Who is the listed applicant for CosmoLock Pedicle Screw System?

The FDA 510(k) record lists Kalitec Direct, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Kalitec Direct, LLC 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.

K180401TiWAVE-C™ Porous Titanium Cervical CageK172086Matira™ Anterior Cervical SystemK170342Ocata Anterior Cervical SystemK163471Kalitec Direct InSePtion™ MIS Fixation 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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