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FDA 510(k)

The JASPER Spinal Fixation System II

K-Number: K190762 · 2019-06-19

ApplicantGbs Commonwealth Co., Ltd.
Decision Date2019-06-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The JASPER Spinal Fixation System II is the device name listed in this FDA 510(k) record. The listed applicant is Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K190762. 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 The JASPER Spinal Fixation System II?

The JASPER Spinal Fixation System II is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K190762.

When did The JASPER Spinal Fixation System II receive FDA 510(k) clearance?

The JASPER Spinal Fixation System II received FDA 510(k) clearance on 2019-06-19, under 510(k) number K190762.

Who is the listed applicant for The JASPER Spinal Fixation System II?

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

What is the FDA product code for The JASPER Spinal Fixation System II?

The FDA product code for The JASPER Spinal Fixation System II is NKB.

Other records listing Gbs Commonwealth Co., Ltd. as applicant

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K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion systemK233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion systemK232292Peridot-EX Expandable Intervertebral Body Fusion SystemK232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)K213755Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion 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.

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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