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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 a medical device manufactured by Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2019-06-19 under approval 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. It is manufactured by Gbs Commonwealth Co., Ltd.. The 510(k) number is K190762.

When was The JASPER Spinal Fixation System II approved by the FDA?

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

What company makes The JASPER Spinal Fixation System II?

The JASPER Spinal Fixation System II is manufactured by Gbs Commonwealth Co., Ltd..

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.

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by Gbs Commonwealth Co., Ltd.

K182059Prase MIS Spinal System K173645JASPER Spinal Fixation System K192026Peridot Intervertebral body fusion System K211205Prase-C Anterior Cervical Plate System K202872Prase PEEK Anterior Cervical Interbody Spacer K202878Prase-AP Anterior Cervical Plate System

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Related Devices (Code: NKB)

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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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