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 a medical device manufactured by 4Web, Inc.. It received FDA 510(k) clearance on 2020-05-29 under approval 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. It is manufactured by 4Web, Inc.. The 510(k) number is K200002.
When was Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device approved by the FDA?
Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device received FDA 510(k) clearance on 2020-05-29, under approval number K200002.
What company makes Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device?
Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device is manufactured by 4Web, Inc..
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.
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Other Devices by 4Web, Inc.
K153436LATERAL Spine Truss System
K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device
K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device
K170851Anterior Spine Truss System (STS) Interbody Fusion Device
K172294Osteotomy Truss System (OTS)
K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device
Related Devices (Code: OVD)
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K161993Leva® Anterior Interbody SystemSpine Wave, Inc.
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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.