Identity
- Trade Name
- LIGAPASS FDA UDI
- Generic Name
- Internal orthopaedic fixation system, cerclage wire/cable, sterile FDA UDI
- Device Name
- LIGAPASS 2.0 DUAL BAND FDA UDI
- Model / Reference
- B08110010 FDA UDI
- Description
- LIGAPASS 2.0 DUAL BAND FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03613720271284 FDA UDI
- 510(k) Number
- K173506 FDA UDI
- FDA Product Code
- OWI FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, cerclage wire/cable, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Internal orthopaedic fixation system, cerclage wire/cable, sterile
Ligapass by Medicrea International SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173506 also covers:
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
- Medicrea International SA
Sources (1)
- FDA UDI 9269ce0c-4daa-4852-91ae-6500d022137c 34 fields · synced May 30, 2026