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FDA 510(k)

WAVE O CAGE

K-Number: K121330 · 2012-06-29

ApplicantAdvanced Medical Technologies AG
Decision Date2012-06-29
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WAVE O 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 2012-06-29 under 510(k) number K121330. 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 WAVE O CAGE?

WAVE O CAGE is a medical device that received FDA 510(k) clearance on 2012-06-29. The listed applicant is Advanced Medical Technologies AG. The 510(k) number is K121330.

When did WAVE O CAGE receive FDA 510(k) clearance?

WAVE O CAGE received FDA 510(k) clearance on 2012-06-29, under 510(k) number K121330.

Who is the listed applicant for WAVE O 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 WAVE O CAGE?

The FDA product code for WAVE O CAGE is MAX.

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 CAGEK121288FUSE CAGEK121332LOOP CAGEK100945FUSE PLIF CAFEK080401SHELL CAGE, WAVE CAGE, LOOP CAGEK033148ART 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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