Identity
- Trade Name
- EVOLUTION® FDA UDI
- Generic Name
- Orthopaedic implant/instrument assembling device FDA UDI
- Device Name
- EVOLUTION® TIBIA MODULAR 2/4/10 STYLUS ASSEMBLY FDA UDI
- Model / Reference
- E2100210CN FDA UDI
- Description
- EVOLUTION® TIBIA MODULAR 2/4/10 STYLUS ASSEMBLY FDA UDI
Identifiers
- Catalog Number
- E2100210CN FDA UDI
- Primary DI / UDI-DI
- 00192629271685 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Orthopaedic implant/instrument assembling device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant/instrument assembling device
Evolution® by MicroPort Orthopedics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant/instrument assembling device.
- FB Broach Handle 135 — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- GIZA — Eden Spine Europe SA · Class I
- Tibial Tray Handle — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- EVOLVE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- ACUMED — ACUMED LLC · Class I
- ACUMED — ACUMED LLC · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI e842f4ab-374c-4758-8d4e-a0b127826492 35 fields · synced Jun 9, 2026