Identity
- Trade Name
- BiOM T2 FDA UDI
- Generic Name
- Dynamic-response foot prosthesis FDA UDI
- Device Name
- BiOM T2 Black (Ankle only) FDA UDI
- Model / Reference
- 11-03B FDA UDI
- Description
- BiOM T2 Black (Ankle only) FDA UDI
Identifiers
- Primary DI / UDI-DI
- B1551103B0 FDA UDI
- FDA Product Code
- ISW FDA UDI
- GMDN Term
- Dynamic-response foot prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3500 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dynamic-response foot prosthesis
BiOM T2 by Bionx Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dynamic-response foot prosthesis.
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- Empower — OTTO BOCK HEALTHCARE · Class II
- Empower — OTTO BOCK HEALTHCARE · Class II
- Empower — OTTO BOCK HEALTHCARE · Class II
- Empower — OTTO BOCK HEALTHCARE · Class II
- Empower — OTTO BOCK HEALTHCARE · 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
- Bionx Medical Technologies, Inc.
Sources (1)
- FDA UDI c26ca66c-4e87-4a66-8b43-24b5d88604ae 33 fields · synced Jun 1, 2026