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FDA 510(k)

Spinal Elements Ti-Bond coated devices

K-Number: K181837 · 2018-11-02

ApplicantSpinal Elements, Inc.
Decision Date2018-11-02
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spinal Elements Ti-Bond coated devices is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2018-11-02 under approval number K181837. 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 Spinal Elements Ti-Bond coated devices?

Spinal Elements Ti-Bond coated devices is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K181837.

When was Spinal Elements Ti-Bond coated devices approved by the FDA?

Spinal Elements Ti-Bond coated devices received FDA 510(k) clearance on 2018-11-02, under approval number K181837.

What company makes Spinal Elements Ti-Bond coated devices?

Spinal Elements Ti-Bond coated devices is manufactured by Spinal Elements, Inc..

What is the FDA product code for Spinal Elements Ti-Bond coated devices?

The FDA product code for Spinal Elements Ti-Bond coated devices is MAX.

Related Clinical Trials

NCT07217314 Testing Non-Invasive Spinal Stimulation Devices RECRUITING NCT05856370 The Ailliance Post-Market Clinical Study RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07578454 VRehab-SMA Phase 1.2 NOT_YET_RECRUITING NCT05587010 Comparison of Gait in Different Support Conditions for Foot Drop COMPLETED NCT06534073 Baropodometric Patterns Associated With Metatarsalgia ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026) PMID: 41747807 Silicone-oil migration in prefilled syringes induces smoke-like particulates in ultra-high viscosity formulations. Journal of pharmaceutical sciences (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026) PMID: 40573269 Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union. Pharmaceuticals (Basel, Switzerland) (2025)

Other Devices by Spinal Elements, Inc.

K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System K160465Spinal Elements' Spinous Process Plate System K152011Lucent Intervertebral Body Fusion Device K170235Lucent® K182584Lucent® XP K180728Spinal Elements Cerclage System

View all 24 devices →

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.

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