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FDA 510(k)

NEST Interbody System

K-Number: K180230 · 2019-01-25

ApplicantPaonan Biotech Co., Ltd.
Decision Date2019-01-25
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEST Interbody System is a medical device manufactured by Paonan Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-01-25 under approval number K180230. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEST Interbody System?

NEST Interbody System is a medical device that received FDA 510(k) clearance on 2019-01-25. It is manufactured by Paonan Biotech Co., Ltd.. The 510(k) number is K180230.

When was NEST Interbody System approved by the FDA?

NEST Interbody System received FDA 510(k) clearance on 2019-01-25, under approval number K180230.

What company makes NEST Interbody System?

NEST Interbody System is manufactured by Paonan Biotech Co., Ltd..

What is the FDA product code for NEST Interbody System?

The FDA product code for NEST Interbody System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Paonan Biotech Co., Ltd.

K161225Paonan Armstrong Posterior Spinal Fixation System K180226TREND II Spinal Fixation System- STEP Series K182285PK High Tibial Osteotomy Correction System K180228II-Type Intervertebral Spacer K220261NEST-C Interbody System

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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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