Identity
- Trade Name
- Columbus® FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Device Name
- COLUMBUS TIB.HEMI-SPACER T2/2+ 4MM RM/LL FDA UDI
- Model / Reference
- NN566K FDA UDI
- Description
- COLUMBUS TIB.HEMI-SPACER T2/2+ 4MM RM/LL FDA UDI
Identifiers
- Catalog Number
- NN566K FDA UDI
- Primary DI / UDI-DI
- 04038653424610 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Knee arthroplasty wedge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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
No
FDA UDI
Category: Knee arthroplasty wedge
Columbus® by Aesculap, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- Unity Total Knee System — CORIN LTD · 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
- Aesculap, Inc.
Sources (1)
- FDA UDI e80c00ac-e27d-4cc1-a163-34607e0c98f1 36 fields · synced Jun 7, 2026