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

FDA 510(k)

SurgTech Interbody System

K-Number: K152200 · 2016-03-25

ApplicantSurgtech, Inc.
Decision Date2016-03-25
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SurgTech Interbody System is a medical device manufactured by Surgtech, Inc.. It received FDA 510(k) clearance on 2016-03-25 under approval number K152200. 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 SurgTech Interbody System?

SurgTech Interbody System is a medical device that received FDA 510(k) clearance on 2016-03-25. It is manufactured by Surgtech, Inc.. The 510(k) number is K152200.

When was SurgTech Interbody System approved by the FDA?

SurgTech Interbody System received FDA 510(k) clearance on 2016-03-25, under approval number K152200.

What company makes SurgTech Interbody System?

SurgTech Interbody System is manufactured by Surgtech, Inc..

What is the FDA product code for SurgTech Interbody System?

The FDA product code for SurgTech Interbody System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Surgtech, Inc.

K162125MALUC™ Total Hip Arthroplasty System K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation System K161894SurgTech Trauma System K173455SurgTech Bipolar Head System K191192SurgTech GENOLL Total Knee System

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.

↑