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FDA 510(k)

Libra Pedicle Screw System

K-Number: K162750 · 2016-10-27

ApplicantSpinal Balance, Inc.
Decision Date2016-10-27
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Libra Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Balance, Inc.. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K162750. 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 Libra Pedicle Screw System?

Libra Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Spinal Balance, Inc.. The 510(k) number is K162750.

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

Libra Pedicle Screw System received FDA 510(k) clearance on 2016-10-27, under 510(k) number K162750.

Who is the listed applicant for Libra Pedicle Screw System?

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

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

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

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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