Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

aprevo® anterior lumbar interbody fusion device with interfixation

K-Number: K222009 · 2022-11-22

ApplicantCarlsmed, Inc.
Decision Date2022-11-22
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aprevo® anterior lumbar interbody fusion device with interfixation is the device name listed in this FDA 510(k) record. The listed applicant is Carlsmed, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K222009. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the aprevo® anterior lumbar interbody fusion device with interfixation?

aprevo® anterior lumbar interbody fusion device with interfixation is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Carlsmed, Inc.. The 510(k) number is K222009.

When did aprevo® anterior lumbar interbody fusion device with interfixation receive FDA 510(k) clearance?

aprevo® anterior lumbar interbody fusion device with interfixation received FDA 510(k) clearance on 2022-11-22, under 510(k) number K222009.

Who is the listed applicant for aprevo® anterior lumbar interbody fusion device with interfixation?

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® anterior lumbar interbody fusion device with interfixation?

The FDA product code for aprevo® anterior lumbar interbody fusion device with interfixation is OVD.

Related Clinical Trials

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.

NCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITINGNCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITINGNCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITINGNCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING

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

View all 22 devices →

Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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.

↑