Depuy Conduit Llif Squid Inserter
Enztec
FDA Clearance Information
The Depuy Conduit LLIF Squid Inserter was cleared through the FDA 510k pathway on June 28, 2022. Manufactured by Enztec, it is classified as a Class 2 device under product code MAX.
What It Is
FDA-Cleared Indications
- The device is cleared under FDA 510(k) K220449 as a Class II device with product code MAX.
- The supplied FDA indication is listed only as “Summary”; specific indications for use are not available in the provided record.
Clinical Applications
- Use in connection with lateral lumbar interbody fusion procedures, as described by the device name and available record.
- Use by trained orthopedic or neurosurgical personnel during lumbar spine surgery, according to the manufacturer’s labeling and surgical technique.
Practical Considerations
- Confirm the exact FDA-cleared intended use in the complete 510(k) decision summary and current manufacturer instructions for use before clinical use.
- This is a surgical instrument rather than an implant; it should be used only with the compatible LLIF system, implant, and delivery components specified by the manufacturer.
- The supplied record does not identify available sizes, working dimensions, sterilization instructions, or compatibility with other systems.
- MRI safety or conditional labeling is not established in the supplied information; do not assume the instrument is MRI safe.
- Use requires appropriate training in LLIF technique, sterile handling, device inspection, and the manufacturer’s precautions and contraindications.
Linked Studies (6)
Embolization of middle meningeal artery for chronic subdural hematoma: Do we have sufficient evidence?
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →Life History of the Arctic Squid Gonatus fabricii (Cephalopoda: Oegopsida) Reconstructed by Analysis of Individual Ontogenetic Stable Isotopic Trajectories.
Animals : an open access journal from MDPI
View Source →Oral administration of squid lecithin-transphosphatidylated phosphatidylserine improves memory impairment in aged rats.
Progress in neuro-psychopharmacology & biological psychiatry
View Source →Temperature dependence of bistability in squid giant axons with alkaline intracellular pH.
The Journal of membrane biology
RCT|prospective|retrospective|case Series|other View Source →Relationship between presynaptic calcium current and postsynaptic potential in squid giant synapse.
Biophysical journal
Other View Source →Electrical properties of the squid axon sheath.
Biophysical journal
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Depuy Conduit LLIF Squid Inserter used for?
It is used for the precise insertion of liquid embolization agents during lateral lumbar interbody fusion procedures.
What specialties typically use this device?
Orthopedic and neurosurgeons commonly use this device in spinal surgery settings.
What are the FDA-cleared indications?
The device is indicated for use in delivering liquid embolization agents during spinal stabilization procedures, particularly in patients with degenerative disc disease or spinal deformities.