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FDA 510(k)

NEO Pedicle Screw System™

K-Number: K171582 · 2017-09-12

ApplicantNeo Medical SA
Decision Date2017-09-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEO Pedicle Screw System™ is the device name listed in this FDA 510(k) record. The listed applicant is Neo Medical SA. It received FDA 510(k) clearance on 2017-09-12 under 510(k) number K171582. 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 NEO Pedicle Screw System™?

NEO Pedicle Screw System™ is a medical device that received FDA 510(k) clearance on 2017-09-12. The listed applicant is Neo Medical SA. The 510(k) number is K171582.

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

NEO Pedicle Screw System™ received FDA 510(k) clearance on 2017-09-12, under 510(k) number K171582.

Who is the listed applicant for NEO Pedicle Screw System™?

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

What is the FDA product code for NEO Pedicle Screw System™?

The FDA product code for NEO Pedicle Screw System™ is NKB.

Other records listing Neo Medical SA 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.

K243693NEO Pedicle Screw System™K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemK191796Neo Cage SystemK181048Neo Cage System TM

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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