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)

GAIA Lumbar Interbody Fusion Device (LIFD) Family

K-Number: K201939 · 2020-10-08

ApplicantPrinterprezz
Decision Date2020-10-08
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAIA Lumbar Interbody Fusion Device (LIFD) Family is a medical device manufactured by Printerprezz. It received FDA 510(k) clearance on 2020-10-08 under approval number K201939. 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 GAIA Lumbar Interbody Fusion Device (LIFD) Family?

GAIA Lumbar Interbody Fusion Device (LIFD) Family is a medical device that received FDA 510(k) clearance on 2020-10-08. It is manufactured by Printerprezz. The 510(k) number is K201939.

When was GAIA Lumbar Interbody Fusion Device (LIFD) Family approved by the FDA?

GAIA Lumbar Interbody Fusion Device (LIFD) Family received FDA 510(k) clearance on 2020-10-08, under approval number K201939.

What company makes GAIA Lumbar Interbody Fusion Device (LIFD) Family?

GAIA Lumbar Interbody Fusion Device (LIFD) Family is manufactured by Printerprezz.

What is the FDA product code for GAIA Lumbar Interbody Fusion Device (LIFD) Family?

The FDA product code for GAIA Lumbar Interbody Fusion Device (LIFD) Family is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05072483 Natural History Study of CADASIL RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026) PMID: 39964125 Potential health benefits of lactoferrin and derived peptides - how to qualify as a medical device? Critical reviews in microbiology (2025)

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.

↑