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FDA 510(k)

E3D™-A Interbody System

K-Number: K240368 · 2024-05-15

ApplicantEvolution Spine
Decision Date2024-05-15
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

E3D™-A Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Spine. It received FDA 510(k) clearance on 2024-05-15 under 510(k) number K240368. 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 E3D™-A Interbody System?

E3D™-A Interbody System is a medical device that received FDA 510(k) clearance on 2024-05-15. The listed applicant is Evolution Spine. The 510(k) number is K240368.

When did E3D™-A Interbody System receive FDA 510(k) clearance?

E3D™-A Interbody System received FDA 510(k) clearance on 2024-05-15, under 510(k) number K240368.

Who is the listed applicant for E3D™-A Interbody System?

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

What is the FDA product code for E3D™-A Interbody System?

The FDA product code for E3D™-A Interbody System is OVD.

Other records listing Evolution Spine 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.

K262094E3D™-C Interbody SystemK260038E3D™-C Interbody SystemK250167Evolution Spine Navigation InstrumentsK241846E3D™-C Interbody SystemK232432E3D™-A Interbody SystemK223146EVOLUTION SPINE Interbody System

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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.

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