Identity
- Trade Name
- Advance FDA UDI
- Generic Name
- Coated knee tibia prosthesis FDA UDI
- Device Name
- ADVANCE® BIOFOAM® TIBIA BASE W/ SCREWHOLES SIZE 3+ FDA UDI
- Model / Reference
- KTSSFM31 FDA UDI
- Description
- ADVANCE® BIOFOAM® TIBIA BASE W/ SCREWHOLES SIZE 3+ FDA UDI
Identifiers
- Catalog Number
- KTSSFM31 FDA UDI
- Primary DI / UDI-DI
- M684KTSSFM311 FDA UDI
- FDA Product Code
- MBH FDA UDI
- GMDN Term
- Coated knee tibia prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Coated knee tibia prosthesis
Advance by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated knee tibia prosthesis.
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- Columbus® CR/PS — AESCULAP, INC. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class I
- AGC KNEE SYSTEM — Biomet Orthopedics, Inc. · Class II
- GMK Total Knee System — Medacta International · Class II
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 |
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Manufacturer
- Manufacturer
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI 8e50d719-d60f-4f5c-b4c9-03a31f22b9ac 35 fields · synced Jun 9, 2026