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FDA 510(k)

NEST-C Interbody System

K-Number: K220261 · 2023-04-24

ApplicantPaonan Biotech Co., Ltd.
Decision Date2023-04-24
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEST-C Interbody System is a medical device manufactured by Paonan Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-04-24 under approval number K220261. 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 NEST-C Interbody System?

NEST-C Interbody System is a medical device that received FDA 510(k) clearance on 2023-04-24. It is manufactured by Paonan Biotech Co., Ltd.. The 510(k) number is K220261.

When was NEST-C Interbody System approved by the FDA?

NEST-C Interbody System received FDA 510(k) clearance on 2023-04-24, under approval number K220261.

What company makes NEST-C Interbody System?

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

What is the FDA product code for NEST-C Interbody System?

The FDA product code for NEST-C Interbody System is ODP.

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 K180230NEST Interbody System K180228II-Type Intervertebral Spacer

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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