Viper Prime
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- VIPER PRIME EUDAMEDFDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Viper Fenestrated Bone Screws - Cortical Fix Polyaxial Screw, X-Tab Polyaxial Screw EUDAMEDVIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 4.5 x 55mm FDA UDI
- Model / Reference
- Viper Fenestrated Bone Screws EUDAMED186745455S EUDAMEDFDA UDI
- Description
- VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 4.5 x 55mm FDA UDI
Identifiers
- Catalog Number
- 186745455S FDA UDI
- Primary DI / UDI-DI
- 10705034529868 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a002486A EUDAMED
- 510(k) Number
- K173095 FDA UDI
- FDA Product Code
- KWQ FDA UDIKWP FDA UDINKB FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3050 FDA UDI888.3070 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
Category: Spinal bone screw, non-bioabsorbable
Viper Prime by Medos International Sarl — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
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- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a002486A | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED a8ff9e6c-87a1-4dd9-87f6-ac0f4704b0c8 61 fields · synced Jul 10, 2026
- FDA UDI 7bce8b4a-f200-4013-9130-49e150c70430 36 fields · synced May 30, 2026