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)

SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX

K-Number: K070181 · 2007-04-18

ApplicantSintea Biotech, Inc.
Decision Date2007-04-18
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX is the device name listed in this FDA 510(k) record. The listed applicant is Sintea Biotech, Inc.. It received FDA 510(k) clearance on 2007-04-18 under 510(k) number K070181. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX?

SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX is a medical device that received FDA 510(k) clearance on 2007-04-18. The listed applicant is Sintea Biotech, Inc.. The 510(k) number is K070181.

When did SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX receive FDA 510(k) clearance?

SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX received FDA 510(k) clearance on 2007-04-18, under 510(k) number K070181.

Who is the listed applicant for SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX?

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

What is the FDA product code for SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX?

The FDA product code for SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX is MQP.

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 Sintea Biotech, 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.

K082679LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.XK081631SINTEA BIOTECH PLS MULTI-AXIAL SCREWSK072198X-VOID, SPIDERK060513SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.XK043355SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.XK041989SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X

View all 10 devices →

Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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.

↑