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FDA 510(k)

JASPER Spinal Fixation System

K-Number: K173645 · 2018-07-23

ApplicantGbs Commonwealth Co., Ltd.
Decision Date2018-07-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JASPER Spinal Fixation System is a medical device manufactured by Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2018-07-23 under approval number K173645. 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 JASPER Spinal Fixation System?

JASPER Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2018-07-23. It is manufactured by Gbs Commonwealth Co., Ltd.. The 510(k) number is K173645.

When was JASPER Spinal Fixation System approved by the FDA?

JASPER Spinal Fixation System received FDA 510(k) clearance on 2018-07-23, under approval number K173645.

What company makes JASPER Spinal Fixation System?

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

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Gbs Commonwealth Co., Ltd.

K182059Prase MIS Spinal System K192026Peridot Intervertebral body fusion System K190762The JASPER Spinal Fixation System II 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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