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FDA 510(k)

II-Type Intervertebral Spacer

K-Number: K180228 · 2019-01-11

ApplicantPaonan Biotech Co., Ltd.
Decision Date2019-01-11
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

II-Type Intervertebral Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Paonan Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K180228. 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 II-Type Intervertebral Spacer?

II-Type Intervertebral Spacer is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Paonan Biotech Co., Ltd.. The 510(k) number is K180228.

When did II-Type Intervertebral Spacer receive FDA 510(k) clearance?

II-Type Intervertebral Spacer received FDA 510(k) clearance on 2019-01-11, under 510(k) number K180228.

Who is the listed applicant for II-Type Intervertebral Spacer?

The FDA 510(k) record lists Paonan Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for II-Type Intervertebral Spacer?

The FDA product code for II-Type Intervertebral Spacer is MAX.

Other records listing Paonan Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220261NEST-C Interbody SystemK182285PK High Tibial Osteotomy Correction SystemK180230NEST Interbody SystemK180226TREND II Spinal Fixation System- STEP SeriesK161225Paonan Armstrong Posterior Spinal Fixation System

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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