Identity
- Trade Name
- EVOLUTION FDA UDI
- Generic Name
- Orthopaedic implant aiming/guiding block attachment tool FDA UDI
- Device Name
- EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 2MM FDA UDI
- Model / Reference
- E1503022 FDA UDI
- Description
- EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 2MM FDA UDI
Identifiers
- Catalog Number
- E1503022 FDA UDI
- Primary DI / UDI-DI
- M684E15030221 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Orthopaedic implant aiming/guiding block attachment tool 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
Yes
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 aiming/guiding block attachment tool
Evolution by MicroPort Orthopedics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant aiming/guiding block attachment tool.
- Phantom Hindfoot TTC/TC Nail System — Paragon 28 · Class II
- OptimalMTP® — Forma Medical, Inc. · Class II
- VA-LCP — Synthes · Class II
- ALIF VERTIGRAFT — Depuy Spine, Inc. · Class I
- Baby Gorilla®/Gorilla® Plating System — Paragon 28 · Class I
- LCP — Synthes · Class I
- Tools - Screws — Trimed, INC. · Class I
- Tools - WFS (C) — Trimed, INC. · 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 c9f7129b-bf39-404c-a545-beb5fcb049c8 35 fields · synced Jun 9, 2026