Identity
- Trade Name
- EVOS FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- EVOS 4.5MM X 20MM LOCKING SCREW SELF-TAPPING FDA UDI
- Model / Reference
- 72514520N FDA UDI
- Description
- EVOS 4.5MM X 20MM LOCKING SCREW SELF-TAPPING FDA UDI
Identifiers
- Catalog Number
- 72514520N FDA UDI
- Primary DI / UDI-DI
- 00885556751084 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Evos by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
- ARIX System Bone Screw — Jeil Medical Corporation · Class II
Cleared under the same submission
K201918 also covers:
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
K213126 also covers:
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CONQUEST FN — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 6c687144-538f-430c-a547-c151ed89c635 36 fields · synced Jun 8, 2026