ORTHOLOC 3DSi
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Ortholoc® 3DSi EUDAMEDORTHOLOC 3DSi FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- CLAW II IMPLANTS - LOCKING CANCELLOUS SCREW - STAINLESS STEEL - CLASS IIB - NONSTERILE EUDAMED
- Model / Reference
- 40223526 EUDAMEDFDA UDI08858251006381TP EUDAMED
Identifiers
- Catalog Number
- 40223526 FDA UDI
- Primary DI / UDI-DI
- 00840420110169 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251006381TP EUDAMED
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
Yes
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
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 3.5 Millimeter FDA UDILength — 26 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
ORTHOLOC 3DSi by Wright Medical Technology, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Wright Medical Technology, Inc.
Sources (2)
- FDA UDI 7d5db543-08d1-492b-90fe-6ba2a68a3874 35 fields · synced Oct 7, 2026
- EUDAMED 41f7ce68-ad11-46ba-b71d-cdb0a24bb7d1 61 fields · synced Oct 7, 2026