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FDA 510(k)

Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device

K-Number: K200002 · 2020-05-29

Applicant4Web, Inc.
Decision Date2020-05-29
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K200002. 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 Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device?

Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is 4Web, Inc.. The 510(k) number is K200002.

When did Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device receive FDA 510(k) clearance?

Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device received FDA 510(k) clearance on 2020-05-29, under 510(k) number K200002.

Who is the listed applicant for Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device?

The FDA 510(k) record lists 4Web, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device?

The FDA product code for Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device 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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITINGNCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITINGNCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITINGNCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING

Other records listing 4Web, 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.

K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)K190926Hammertoe Truss System (HTS)K172294Osteotomy Truss System (OTS)K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device

View all 11 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.

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