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)

Curiteva Porous PEEK Standalone ALIF System

K-Number: K250845 · 2025-06-18

ApplicantCuriteva, Inc.
Decision Date2025-06-18
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Curiteva Porous PEEK Standalone ALIF System is a medical device manufactured by Curiteva, Inc.. It received FDA 510(k) clearance on 2025-06-18 under approval number K250845. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Curiteva Porous PEEK Standalone ALIF System?

Curiteva Porous PEEK Standalone ALIF System is a medical device that received FDA 510(k) clearance on 2025-06-18. It is manufactured by Curiteva, Inc.. The 510(k) number is K250845.

When was Curiteva Porous PEEK Standalone ALIF System approved by the FDA?

Curiteva Porous PEEK Standalone ALIF System received FDA 510(k) clearance on 2025-06-18, under approval number K250845.

What company makes Curiteva Porous PEEK Standalone ALIF System?

Curiteva Porous PEEK Standalone ALIF System is manufactured by Curiteva, Inc..

What is the FDA product code for Curiteva Porous PEEK Standalone ALIF System?

The FDA product code for Curiteva Porous PEEK Standalone ALIF System is OVD.

Related Clinical Trials

NCT07526818 Comparison of Manual and Mechanical Glide Path Techniques for Measuring Root Canal Length Using Standalone Apex Locator and an Endomotor With built-in Apex Locator. ACTIVE_NOT_RECRUITING NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING

Other Devices by Curiteva, Inc.

K191810Curiteva Pedicle Screw System K210402Curiteva Sacroiliac Joint Fusion System K231232Curiteva Laminoplasty System K213030Curiteva Porous PEEK Cervical Interbody Fusion System K223200Curiteva Navigation System K243137Curiteva Porous PEEK Laminoplasty System

View all 11 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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.

↑