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FDA 510(k)

InterForm Cervical Interbody Cage System

K-Number: K161608 · 2016-09-30

ApplicantNext Orthosurgical
Decision Date2016-09-30
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

InterForm Cervical Interbody Cage System is a medical device manufactured by Next Orthosurgical. It received FDA 510(k) clearance on 2016-09-30 under approval number K161608. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InterForm Cervical Interbody Cage System?

InterForm Cervical Interbody Cage System is a medical device that received FDA 510(k) clearance on 2016-09-30. It is manufactured by Next Orthosurgical. The 510(k) number is K161608.

When was InterForm Cervical Interbody Cage System approved by the FDA?

InterForm Cervical Interbody Cage System received FDA 510(k) clearance on 2016-09-30, under approval number K161608.

What company makes InterForm Cervical Interbody Cage System?

InterForm Cervical Interbody Cage System is manufactured by Next Orthosurgical.

What is the FDA product code for InterForm Cervical Interbody Cage System?

The FDA product code for InterForm Cervical Interbody Cage System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING

Other Devices by Next Orthosurgical

K161499VertiForm Posterior Fixation System K190981NEX-D2 Posterior Fixation System K242509HAnano InterFuse(R) Modular Interbody

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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