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FDA 510(k)

PERLA® Posterior Occipito-Cervico-Thoracic Fixation System

K-Number: K200571 · 2020-05-01

ApplicantSpineart
Decision Date2020-05-01
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERLA® Posterior Occipito-Cervico-Thoracic Fixation System is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2020-05-01 under approval number K200571. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERLA® Posterior Occipito-Cervico-Thoracic Fixation System?

PERLA® Posterior Occipito-Cervico-Thoracic Fixation System is a medical device that received FDA 510(k) clearance on 2020-05-01. It is manufactured by Spineart. The 510(k) number is K200571.

When was PERLA® Posterior Occipito-Cervico-Thoracic Fixation System approved by the FDA?

PERLA® Posterior Occipito-Cervico-Thoracic Fixation System received FDA 510(k) clearance on 2020-05-01, under approval number K200571.

What company makes PERLA® Posterior Occipito-Cervico-Thoracic Fixation System?

PERLA® Posterior Occipito-Cervico-Thoracic Fixation System is manufactured by Spineart.

What is the FDA product code for PERLA® Posterior Occipito-Cervico-Thoracic Fixation System?

The FDA product code for PERLA® Posterior Occipito-Cervico-Thoracic Fixation System is NKG.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05639569 Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06658730 Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance RECRUITING

Other Devices by Spineart

K161888JULIET® LL Lateral Lumbar Cage K153621Juliet® Ti K153042TRYPTIK2C-plate Anterior Cervical Plate System K153386Perla Posterior Cervico-Thoracic Fixation system K151104OTELO LL K172065SCARLET AC-T

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Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

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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