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FDA 510(k)

SHELL CAGE, WAVE CAGE, LOOP CAGE

K-Number: K080401 · 2008-05-09

ApplicantAdvanced Medical Technologies AG
Decision Date2008-05-09
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SHELL CAGE, WAVE CAGE, LOOP CAGE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Technologies AG. It received FDA 510(k) clearance on 2008-05-09 under 510(k) number K080401. 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 SHELL CAGE, WAVE CAGE, LOOP CAGE?

SHELL CAGE, WAVE CAGE, LOOP CAGE is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is Advanced Medical Technologies AG. The 510(k) number is K080401.

When did SHELL CAGE, WAVE CAGE, LOOP CAGE receive FDA 510(k) clearance?

SHELL CAGE, WAVE CAGE, LOOP CAGE received FDA 510(k) clearance on 2008-05-09, under 510(k) number K080401.

Who is the listed applicant for SHELL CAGE, WAVE CAGE, LOOP CAGE?

The FDA 510(k) record lists Advanced Medical Technologies AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHELL CAGE, WAVE CAGE, LOOP CAGE?

The FDA product code for SHELL CAGE, WAVE CAGE, LOOP CAGE is MAX.

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Other records listing Advanced Medical Technologies AG 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.

K121333WAVE D CAGEK121332LOOP CAGEK121288FUSE CAGEK121330WAVE O CAGEK100945FUSE PLIF CAFEK033148ART ANTERIOR SPINAL SYSTEM

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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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