Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Z-Guide Wire EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone staple drill bit FDA UDI
- Device Name
- Z-Guide Wire EUDAMEDZ-Guide Wire Ø3,2 x 100 FDA UDI
- Model / Reference
- B01 253 S EUDAMEDFDA UDIZ-Guide Wire EUDAMED
- Description
- Z-Guide Wire Ø3,2 x 100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057217004563 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057217Z-GUIDEWIRESAP EUDAMED
- 510(k) Number
- K121277 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)HTY FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Orthopaedic bone staple drill bit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
This device is a set of orthopedic fixation components, including a Z-Snap Off Screw, a Z-Double Thread Compression Screw, a Z-Guide Wire, and a Z-Staple. These components are designed for internal fixation in orthopedic procedures, aiding in the stabilization of bone fractures or surgical repairs.
The device is supplied sterile and intended for single-use in orthopedic settings. It is classified under product code HWC and has received FDA 510(k) clearance and MDR authorization. The screws and staples are engineered for compression and secure fixation, while the guide wire assists in precise placement during surgical procedures.
Frequently asked questions
What types of orthopedic procedures is this fixation set designed to assist with?
This set is designed for internal fixation in orthopedic procedures, specifically to stabilize bone fractures or surgical repairs. The components—including screws and staples—are engineered for compression and secure fixation, while the guide wire aids in precise placement during surgery. It is not intended for any other clinical applications beyond these stabilization purposes.
Is this device intended for reuse or single-use, and how is it supplied?
This device is explicitly intended for single-use only in orthopedic settings. It is supplied sterile, ensuring readiness for immediate surgical use without the need for additional sterilization or reprocessing.
What regulatory pathways has this device undergone, and what does that mean for its use?
The device has received FDA 510(k) clearance under the Traditional pathway (K121277) and MDR authorization, confirming compliance with both U.S. and EU regulatory standards. This means it has been evaluated for safety and performance in its intended orthopedic fixation applications and is legally marketable in jurisdictions adhering to these frameworks.
How do the screws and staples in this set differ in function, and what role does the guide wire play?
The Z-Snap Off Screw and Z-Double Thread Compression Screw are designed for secure fixation and compression of bone fragments, ensuring stability during healing. The Z-Staple provides an alternative fixation method for certain procedures. The Z-Guide Wire assists surgeons in achieving precise placement of these components, reducing the risk of misalignment during surgery.
What storage requirements should be followed for this sterile orthopedic fixation set?
Since the device is supplied sterile, it should be stored in its original packaging until use to maintain sterility. The packaging should be kept sealed, protected from contamination, and stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer instructions for proper handling and expiration checks.
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 | K121277 | Class II | Active |
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Manufacturer
- Manufacturer
- Z-Medical GmbH & Co. KG
Sources (3)
- FDA 510(k) K121277 24 fields · synced Oct 6, 2026
- FDA UDI e4ef445a-9c51-404a-a28a-b516fcc9c5d9 34 fields · synced May 30, 2026
- EUDAMED bb43c1e0-85f2-40fd-8a41-c9955ae5a273 61 fields · synced Jul 15, 2026