BioPro Go-Ez Screw
FDA 510(k)Class II (US FDA 510(k))
by Biopro, Inc.
Identifiers
- 510(k) Number
- K081149 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BioPro Go-Ez Screw is a metallic bone fixation fastener classified as an orthopedic device. It functions as a mechanical implant designed to stabilize bone segments, facilitating healing in fractures, osteotomies, arthrodeses, and tendon reattachments by providing secure fixation during the repair process.
This screw is supplied sterile and intended for single-use applications. It is available in various sizes, including 3.5 x 14mm (18207) and 3.5 x 32mm (18216), and is intended for use in surgical settings by orthopedic, hand, plastic, and podiatric surgeons. The device has received FDA 510(k) clearance under the traditional pathway, with a classification under the Orthopedic Advisory Committee (OR). No third-party review was involved in its authorization.
Frequently asked questions
What is the BioPro Go-Ez Screw used for?
The BioPro Go-Ez Screw is a metallic orthopedic fixation device designed to stabilize bone segments during surgical repairs. It is specifically intended for use in fractures, osteotomies (controlled bone cuts), arthrodeses (joint fusions), and tendon reattachments. By providing secure mechanical fixation, it helps facilitate proper bone healing and alignment.
Is the BioPro Go-Ez Screw sterile and single-use?
Yes, the BioPro Go-Ez Screw is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the device’s integrity for one surgical procedure.
What sizes are available for the BioPro Go-Ez Screw?
The BioPro Go-Ez Screw is available in two primary sizes: 3.5 x 14mm (reference 18207) and 3.5 x 32mm (reference 18216). These dimensions cater to different clinical needs, such as smaller or larger bone fixation requirements.
Who can use the BioPro Go-Ez Screw in surgery?
The BioPro Go-Ez Screw is intended for use by orthopedic, hand, plastic, and podiatric surgeons in surgical settings. Its design and fixation properties make it suitable for procedures requiring precise bone stabilization.
How is the BioPro Go-Ez Screw stored before use?
While the provided data does not specify storage conditions, sterile single-use devices like this typically require protection from moisture, contamination, and physical damage. It should be stored in its original packaging, away from direct sunlight or extreme temperatures, until ready for use.
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. Sources consulted: BIOPRO GO-EZ SCREW (K081149) — FDA 510 (k) | Innolitics, BIOPRO, INC. 18216 3.5 x 32mm Go-EZ Screw - RevMed, BioPro 2.0-6.5mm Screws: AI Chat & PDF Access | Manualzz, 3.5 x 14mm Go-EZ Screw 18207 GUDID Device - FDA.report, OrthoAxis - Product
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081149 | Class II | Active |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA 510(k) K081149 24 fields · synced Oct 1, 2026