Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE

K-Number: K072120 · 2007-10-11

ApplicantInnovative Spinal Technologies, Inc.
Decision Date2007-10-11
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Spinal Technologies, Inc.. It received FDA 510(k) clearance on 2007-10-11 under 510(k) number K072120. 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 PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE?

PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2007-10-11. The listed applicant is Innovative Spinal Technologies, Inc.. The 510(k) number is K072120.

When did PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE receive FDA 510(k) clearance?

PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE received FDA 510(k) clearance on 2007-10-11, under 510(k) number K072120.

Who is the listed applicant for PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE?

The FDA 510(k) record lists Innovative Spinal Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE?

The FDA product code for PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Innovative Spinal Technologies, Inc. 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.

K072650IST ANTERIOR CERVICAL PLATE SYSTEMK062759PARAMOUNT VBR SYSTEMK053276IST PEDICLE SCREW 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑