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FDA 510(k)

DEPUY SPINE LATERAL CAGE SYSTEM

K-Number: K082128 · 2008-11-14

ApplicantDepuy Spine
Decision Date2008-11-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY SPINE LATERAL CAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine. It received FDA 510(k) clearance on 2008-11-14 under 510(k) number K082128. 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 DEPUY SPINE LATERAL CAGE SYSTEM?

DEPUY SPINE LATERAL CAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Depuy Spine. The 510(k) number is K082128.

When did DEPUY SPINE LATERAL CAGE SYSTEM receive FDA 510(k) clearance?

DEPUY SPINE LATERAL CAGE SYSTEM received FDA 510(k) clearance on 2008-11-14, under 510(k) number K082128.

Who is the listed applicant for DEPUY SPINE LATERAL CAGE SYSTEM?

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

What is the FDA product code for DEPUY SPINE LATERAL CAGE SYSTEM?

The FDA product code for DEPUY SPINE LATERAL CAGE SYSTEM is MAX.

Related Clinical Trials

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.

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Other records listing Depuy 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.

K222276CONDUIT Cages; FIBERGRAFT BG PuttyK101923CONCORDE CURVE SYSTEM

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

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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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