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FDA 510(k)

4-WEB ALIF SPINAL TRUSS SYSTEM (STS)

K-Number: K112316 · 2011-12-14

Applicant4-Web, Inc.
Decision Date2011-12-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4-WEB ALIF SPINAL TRUSS SYSTEM (STS) is the device name listed in this FDA 510(k) record. The listed applicant is 4-Web, Inc.. It received FDA 510(k) clearance on 2011-12-14 under 510(k) number K112316. 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 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)?

4-WEB ALIF SPINAL TRUSS SYSTEM (STS) is a medical device that received FDA 510(k) clearance on 2011-12-14. The listed applicant is 4-Web, Inc.. The 510(k) number is K112316.

When did 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) receive FDA 510(k) clearance?

4-WEB ALIF SPINAL TRUSS SYSTEM (STS) received FDA 510(k) clearance on 2011-12-14, under 510(k) number K112316.

Who is the listed applicant for 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)?

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

What is the FDA product code for 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)?

The FDA product code for 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) is MAX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing 4-Web, 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.

K1301854WEB OSTEOTOMY BONE WEDGEK1217414-WEB CERVICAL STS (SPINAL TRUSS 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.

K261049SCALA® TLSpineart SAK261430TruLift 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.

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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