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FDA 510(k)

HD Lumbar Interbody System

K-Number: K170676 · 2017-07-13

ApplicantHd Lifesciences, LLC
Decision Date2017-07-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HD Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Hd Lifesciences, LLC. It received FDA 510(k) clearance on 2017-07-13 under 510(k) number K170676. 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 HD Lumbar Interbody System?

HD Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2017-07-13. The listed applicant is Hd Lifesciences, LLC. The 510(k) number is K170676.

When did HD Lumbar Interbody System receive FDA 510(k) clearance?

HD Lumbar Interbody System received FDA 510(k) clearance on 2017-07-13, under 510(k) number K170676.

Who is the listed applicant for HD Lumbar Interbody System?

The FDA 510(k) record lists Hd Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HD Lumbar Interbody System?

The FDA product code for HD Lumbar Interbody System is MAX.

Other records listing Hd Lifesciences, LLC 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.

K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemK180364HD LifeSciences Cervical IBFD 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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