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FDA 510(k)

Curiteva Porous PEEK Laminoplasty System

K-Number: K243137 · 2024-10-28

ApplicantCuriteva, Inc.
Decision Date2024-10-28
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Curiteva Porous PEEK Laminoplasty 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 2024-10-28 under 510(k) number K243137. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Curiteva Porous PEEK Laminoplasty System?

Curiteva Porous PEEK Laminoplasty System is a medical device that received FDA 510(k) clearance on 2024-10-28. The listed applicant is Curiteva, Inc.. The 510(k) number is K243137.

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

Curiteva Porous PEEK Laminoplasty System received FDA 510(k) clearance on 2024-10-28, under 510(k) number K243137.

Who is the listed applicant for Curiteva Porous PEEK Laminoplasty 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 Laminoplasty System?

The FDA product code for Curiteva Porous PEEK Laminoplasty System is NQW.

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 SystemK250845Curiteva Porous PEEK Standalone ALIF SystemK233360Curiteva Thoracolumbar Plate SystemK233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemK231232Curiteva Laminoplasty System

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Related Devices (Code: NQW)

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.

K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLCK232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLCK231232Curiteva Laminoplasty SystemCuriteva, Inc.K212428Centerpiece Plate Fixation SystemMedtronic Sofamor DanekK191927Hinged Laminoplasty SystemLife Spine, 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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