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FDA 510(k)

GPS Cervical Spacers

K-Number: K210890 · 2021-04-23

ApplicantG Surgical, LLC
Decision Date2021-04-23
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GPS Cervical Spacers is a medical device manufactured by G Surgical, LLC. It received FDA 510(k) clearance on 2021-04-23 under approval number K210890. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GPS Cervical Spacers?

GPS Cervical Spacers is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by G Surgical, LLC. The 510(k) number is K210890.

When was GPS Cervical Spacers approved by the FDA?

GPS Cervical Spacers received FDA 510(k) clearance on 2021-04-23, under approval number K210890.

What company makes GPS Cervical Spacers?

GPS Cervical Spacers is manufactured by G Surgical, LLC.

What is the FDA product code for GPS Cervical Spacers?

The FDA product code for GPS Cervical Spacers is ODP.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING

Other Devices by G Surgical, LLC

K161516G Surgical Marksman MIS System K171834G Surgical OCT Spinal System K193219G Surgical Marksman System K230063G Surgical Marksman Spinal Deformity System K240737G Surgical Marksman MIS System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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