DePuy CONDUIT LLIF SQUID Inserter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220449 FDA 510(k)
- FDA Product Code
- MAX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DePuy CONDUIT LLIF SQUID Inserter is a surgical instrument classified as a tendon or ligament conduit inserter under orthopedic nomenclature. It is designed to facilitate the insertion of tendon or ligament conduits during minimally invasive procedures, specifically in lateral lumbar interbody fusion (LLIF) surgeries. The device aids in precise conduit placement to support tissue regeneration or reconstruction within the spinal column.
This device is supplied sterile and intended for single-use. It is intended for use in sterile operating room environments and must be handled according to standard surgical protocols. The inserter is regulated under FDA 510(k) clearance and MDR, with a K-number of K220449 and product code MAX. No MRI safety information is specified, and storage conditions align with standard surgical instrument requirements.
Frequently asked questions
What specific type of surgery is the DePuy CONDUIT LLIF SQUID Inserter designed to assist with, and why is precise placement important in this context?
The DePuy CONDUIT LLIF SQUID Inserter is specifically designed for lateral lumbar interbody fusion (LLIF) surgeries, a minimally invasive procedure for the spine. Precise conduit placement is critical because the device aids in positioning tendon or ligament conduits within the spinal column to support tissue regeneration or reconstruction. Accurate insertion ensures proper alignment and integration of the conduit, which is essential for the success of the fusion process and patient recovery.
Is the DePuy CONDUIT LLIF SQUID Inserter reusable, or is it intended for single-use only? How should it be handled to maintain sterility?
The DePuy CONDUIT LLIF SQUID Inserter is explicitly intended for single-use only and is supplied sterile. To maintain sterility, it must be handled according to standard surgical protocols, including keeping the packaging intact until use and adhering to sterile field procedures in the operating room. Reuse is not recommended or supported by the manufacturer.
What storage conditions should be followed for the DePuy CONDUIT LLIF SQUID Inserter, and does it have any special handling requirements?
The DePuy CONDUIT LLIF SQUID Inserter follows standard storage conditions for surgical instruments. It should be stored in a clean, dry environment, protected from physical damage and contamination, and kept within the manufacturer’s recommended temperature and humidity ranges (typically room temperature). Since it is sterile upon packaging, avoid exposing it to moisture, extreme temperatures, or direct sunlight before use.
What regulatory pathways has the DePuy CONDUIT LLIF SQUID Inserter followed, and what does this mean for its use in clinical settings?
The device has undergone FDA 510(k) clearance (K220449) and MDR (Medical Device Regulation) authorization, confirming it meets regulatory standards for safety and effectiveness. This means it has been evaluated by competent authorities and is legally permitted for use in approved clinical settings, including LLIF procedures, as long as it is used according to the manufacturer’s instructions and within its intended surgical context.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220449 | Class II | Active |
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Manufacturer
- Manufacturer
- Enztec Limited
Sources (2)
- FDA 510(k) K220449 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026