Identity
- Trade Name
- Z-Staple EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- Z-Staple EUDAMEDZ-Staple 10 / 15 mm FDA UDI
- Model / Reference
- C03 205 EUDAMEDFDA UDIZ-Staple EUDAMED
- Description
- Z-Staple 10 / 15 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057217003658 EUDAMEDFDA UDI
- Basic UDI-DI
- 4057217Z-STAPLEYT EUDAMED
- FDA Product Code
- JDR FDA UDI
- EMDN Code
- P09120101 OSTEOSYNTHESIS STAPLES EUDAMED
- GMDN Term
- Orthopaedic bone staple, non-adjustable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone staple, non-adjustable
Z-Staple by Z-Medical GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple, non-adjustable.
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- Arthrex® — Arthrex, Inc. · Class II
- Speed Arc — Synthes · Class II
- JAWS Nitinol Staple System — Paragon 28 · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Z-Medical GmbH & Co. KG
Sources (2)
- FDA UDI 41aa2d35-0577-4199-b417-39d39414adf1 34 fields · synced Oct 6, 2026
- EUDAMED a05ff48a-b834-4354-b1a1-be09c0f03233 61 fields · synced Oct 6, 2026