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FDA 510(k)

aprevo Transforaminal IBF

K-Number: K210542 · 2021-06-30

ApplicantCarlsmed, Inc.
Decision Date2021-06-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aprevo Transforaminal IBF is the device name listed in this FDA 510(k) record. The listed applicant is Carlsmed, Inc.. It received FDA 510(k) clearance on 2021-06-30 under 510(k) number K210542. 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 aprevo Transforaminal IBF?

aprevo Transforaminal IBF is a medical device that received FDA 510(k) clearance on 2021-06-30. The listed applicant is Carlsmed, Inc.. The 510(k) number is K210542.

When did aprevo Transforaminal IBF receive FDA 510(k) clearance?

aprevo Transforaminal IBF received FDA 510(k) clearance on 2021-06-30, under 510(k) number K210542.

Who is the listed applicant for aprevo Transforaminal IBF?

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

What is the FDA product code for aprevo Transforaminal IBF?

The FDA product code for aprevo Transforaminal IBF is MAX.

Other records listing Carlsmed, Inc. 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.

K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating systemK260570corra™ cervical plating systemK252894aprevo® cervical interbody systemK252611aprevo® cervical plating systemK250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No CamsK250987aprevo® posterior/transforaminal lumbar interbody fusion device

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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

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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