Identity
- Trade Name
- OIC FLEX-FIX™ System FDA UDI
- Generic Name
- Orthopaedic fixation suture button FDA UDI
- Device Name
- FLEX-FIX SYNDESMOSIS REPAIR KIT FDA UDI
- Model / Reference
- FLEX-01-S FDA UDI
- Description
- FLEX-FIX SYNDESMOSIS REPAIR KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811998039883 FDA UDI
- 510(k) Number
- K233531 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Orthopaedic fixation suture button FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Dimensions & Sizes
- Size
- Length — 6.35 Millimeter FDA UDI
Category: Orthopaedic fixation suture button
OIC FLEX-FIX™ System by Orthopaedic Implant Company, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Orthopaedic Implant Company, The
Sources (1)
- FDA UDI 2cad464c-f64f-45b5-b2ef-9c869a3071c2 36 fields · synced Jun 6, 2026