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FDA 510(k)

FRONTIER SADL INTERBODY FUSION DEVICE

K-Number: K112700 · 2012-11-01

ApplicantFrontier Medical Devices, Inc.
Decision Date2012-11-01
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FRONTIER SADL INTERBODY FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Frontier Medical Devices, Inc.. It received FDA 510(k) clearance on 2012-11-01 under 510(k) number K112700. 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 FRONTIER SADL INTERBODY FUSION DEVICE?

FRONTIER SADL INTERBODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2012-11-01. The listed applicant is Frontier Medical Devices, Inc.. The 510(k) number is K112700.

When did FRONTIER SADL INTERBODY FUSION DEVICE receive FDA 510(k) clearance?

FRONTIER SADL INTERBODY FUSION DEVICE received FDA 510(k) clearance on 2012-11-01, under 510(k) number K112700.

Who is the listed applicant for FRONTIER SADL INTERBODY FUSION DEVICE?

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

What is the FDA product code for FRONTIER SADL INTERBODY FUSION DEVICE?

The FDA product code for FRONTIER SADL INTERBODY FUSION DEVICE is OVD.

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Other records listing Frontier Medical Devices, Inc. as applicant

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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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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