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FDA 510(k)

CarboClear Lumbar Cage System

K-Number: K203683 · 2021-01-15

ApplicantCarbofix Orthpedics , Ltd.
Decision Date2021-01-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CarboClear Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Carbofix Orthpedics , Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203683. 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 CarboClear Lumbar Cage System?

CarboClear Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Carbofix Orthpedics , Ltd.. The 510(k) number is K203683.

When did CarboClear Lumbar Cage System receive FDA 510(k) clearance?

CarboClear Lumbar Cage System received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203683.

Who is the listed applicant for CarboClear Lumbar Cage System?

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

What is the FDA product code for CarboClear Lumbar Cage System?

The FDA product code for CarboClear Lumbar Cage System is MAX.

Other records listing Carbofix Orthpedics , 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.

K222874CarboClear Cervical Cage System, CarboClear Cervical VBR 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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