Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Curiteva, Inc.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) 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. The listed applicant is Curiteva, Inc.. The 510(k) number is K250845.

When did Curiteva Porous PEEK Standalone ALIF System receive FDA 510(k) clearance?

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

Who is the listed applicant for Curiteva Porous PEEK Standalone ALIF System?

The FDA 510(k) record lists Curiteva, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Curiteva, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF SystemK254061Curiteva Porous PEEK Cervical Interbody Fusion SystemK243137Curiteva Porous PEEK Laminoplasty SystemK233360Curiteva Thoracolumbar Plate SystemK233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemK231232Curiteva Laminoplasty System

View all 15 devices →

Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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.

↑