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FDA 510(k)

INTERFORM INTERBODY CAGE SYSTEM

K-Number: K131082 · 2013-08-26

ApplicantNext Orthosurgical
Decision Date2013-08-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERFORM INTERBODY CAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Next Orthosurgical. It received FDA 510(k) clearance on 2013-08-26 under 510(k) number K131082. 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 INTERFORM INTERBODY CAGE SYSTEM?

INTERFORM INTERBODY CAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-26. The listed applicant is Next Orthosurgical. The 510(k) number is K131082.

When did INTERFORM INTERBODY CAGE SYSTEM receive FDA 510(k) clearance?

INTERFORM INTERBODY CAGE SYSTEM received FDA 510(k) clearance on 2013-08-26, under 510(k) number K131082.

Who is the listed applicant for INTERFORM INTERBODY CAGE SYSTEM?

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

What is the FDA product code for INTERFORM INTERBODY CAGE SYSTEM?

The FDA product code for INTERFORM INTERBODY 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 Next Orthosurgical 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.

K242509HAnano InterFuse(R) Modular InterbodyK190981NEX-D2 Posterior Fixation SystemK161608InterForm Cervical Interbody Cage SystemK161499VertiForm Posterior Fixation 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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