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FDA 510(k)

VALEO SPACER SYSTEM

K-Number: K091278 · 2010-01-28

ApplicantAmedica Corp.
Decision Date2010-01-28
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VALEO SPACER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amedica Corp.. It received FDA 510(k) clearance on 2010-01-28 under 510(k) number K091278. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALEO SPACER SYSTEM?

VALEO SPACER SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-28. The listed applicant is Amedica Corp.. The 510(k) number is K091278.

When did VALEO SPACER SYSTEM receive FDA 510(k) clearance?

VALEO SPACER SYSTEM received FDA 510(k) clearance on 2010-01-28, under 510(k) number K091278.

Who is the listed applicant for VALEO SPACER SYSTEM?

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

What is the FDA product code for VALEO SPACER SYSTEM?

The FDA product code for VALEO SPACER SYSTEM is MAX.

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Other records listing Amedica Corp. 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.

K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceK161405Valeo II Interbody Fusion Device SystemK121892PHANTOM PLUS CERAMIC CAGE SYSTEMK082037SEEPLATE CERVICAL PLATE SYSTEMK073430VALEO PEDICLE SCREW SPINAL SYSTEMK073505MODIFICATION TO VALEO VBR

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Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

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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