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FDA 510(k)

Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems

K-Number: K160775 · 2016-06-03

ApplicantChoicespine, LP
Decision Date2016-06-03
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K160775. 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 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems?

Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Choicespine, LP. The 510(k) number is K160775.

When did Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems receive FDA 510(k) clearance?

Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems received FDA 510(k) clearance on 2016-06-03, under 510(k) number K160775.

Who is the listed applicant for Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems?

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

What is the FDA product code for Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems?

The FDA product code for Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is NKB.

Related Clinical Trials

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.

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Other records listing Choicespine, LP as applicant

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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.

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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