Identity
- Trade Name
- OMNISPAN ORTHOCORD FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- OMNISPAN MENISCAL REPAIR SYSTEM / 0 Degrees ORTHOCORD Violet braided composite suture, Size 2-0 (2) PEEK Backstops, and (1) Straight Needle FDA UDI
- Model / Reference
- 228140 FDA UDI
- Description
- OMNISPAN MENISCAL REPAIR SYSTEM / 0 Degrees ORTHOCORD Violet braided composite suture, Size 2-0 (2) PEEK Backstops, and (1) Straight Needle FDA UDI
Identifiers
- Catalog Number
- 228140 FDA UDI
- Primary DI / UDI-DI
- 10886705010028 FDA UDI
- FDA Product Code
- MBI FDA UDIMAI FDA UDIGAT FDA UDINEW FDA UDIHTY FDA UDIJDR FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI878.5000 FDA UDI878.4840 FDA UDI
- Commercial Distribution
- Not 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
Omnispan Orthocord by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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- LUPINE — DePuy Mitek, Inc.
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- MICROFIX QUICKANCHOR ETHIBOND — DePuy Mitek, Inc.
- MICROFIX QUICKANCHOR ETHIBOND — DePuy Mitek, Inc.
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
- Medos International Sàrl
Sources (1)
- FDA UDI 0611ef75-476b-4d6c-8a8a-d3717f0bfafa 38 fields · synced Jun 8, 2026