Posterior Spine Truss System (PSTS) Interbody Fusion Device
K-Number: K171351 · 2017-09-08
Applicant4Web, Inc.
Decision Date2017-09-08
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Posterior Spine Truss System (PSTS) Interbody Fusion Device is a medical device manufactured by 4Web, Inc.. It received FDA 510(k) clearance on 2017-09-08 under approval number K171351. 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 Posterior Spine Truss System (PSTS) Interbody Fusion Device?
Posterior Spine Truss System (PSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2017-09-08. It is manufactured by 4Web, Inc.. The 510(k) number is K171351.
When was Posterior Spine Truss System (PSTS) Interbody Fusion Device approved by the FDA?
Posterior Spine Truss System (PSTS) Interbody Fusion Device received FDA 510(k) clearance on 2017-09-08, under approval number K171351.
What company makes Posterior Spine Truss System (PSTS) Interbody Fusion Device?
Posterior Spine Truss System (PSTS) Interbody Fusion Device is manufactured by 4Web, Inc..
What is the FDA product code for Posterior Spine Truss System (PSTS) Interbody Fusion Device?
The FDA product code for Posterior Spine Truss System (PSTS) Interbody Fusion Device is MAX.
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Other Devices by 4Web, Inc.
K153436LATERAL Spine Truss System
K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device
K170851Anterior Spine Truss System (STS) Interbody Fusion Device
K172294Osteotomy Truss System (OTS)
K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device
K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)
Related Devices (Code: MAX)
K163180Hubble IIOrbbo Surgical, LLC
K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc.
K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL
K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP
K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.
K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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.