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OSSIOfiber® Hammertoe Fixation System
FDA UDIClass II (US FDA UDI)
by Ossio Ltd
Identity
- Trade Name
- OSSIOfiber® Hammertoe Fixation System FDA UDI
- Generic Name
- Orthopaedic bone pin, bioabsorbable FDA UDI
- Device Name
- The OSSIOfiber® Hammertoe Fixation System, M, 2.9X19 mm, angled 10°. Package contains: 1 K-wire, 1 Drill Bit, 1 Inserter, 1 Implant angled 10°. FDA UDI
- Model / Reference
- OF20029191 FDA UDI
- Description
- The OSSIOfiber® Hammertoe Fixation System, M, 2.9X19 mm, angled 10°. Package contains: 1 K-wire, 1 Drill Bit, 1 Inserter, 1 Implant angled 10°. FDA UDI
Identifiers
- Catalog Number
- OF20029191 FDA UDI
- Primary DI / UDI-DI
- 07290017630106 FDA UDI
- 510(k) Number
- K190652 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone pin, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.9 Millimeter FDA UDILength — 19 Millimeter FDA UDI
Category: Orthopaedic bone pin, bioabsorbable
OSSIOfiber® Hammertoe Fixation System by Ossio Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190652 also covers:
- OSSIOfiber® Hammertoe Fixation Implant — OSSIO LTD
- OSSIOfiber® Hammertoe Fixation Implant — OSSIO LTD
- OSSIOfiber® Hammertoe Fixation Implant — OSSIO LTD
- OSSIOfiber® Hammertoe Fixation Implant — OSSIO LTD
- OSSIOfiber® Hammertoe Fixation Implant — OSSIO LTD
- OSSIOfiber® Hammertoe Fixation Implant — OSSIO LTD
- OSSIOfiber® Hammertoe Fixation System — OSSIO LTD
- OSSIOfiber® Hammertoe Fixation System — OSSIO LTD
- OSSIOfiber® Hammertoe Fixation System — OSSIO LTD
- OSSIOfiber® Hammertoe Fixation System — OSSIO LTD
- OSSIOfiber® Hammertoe Fixation System — OSSIO LTD
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
- Ossio Ltd
Sources (1)
- FDA UDI 37635d2e-1494-4a6b-8601-ef7ec1f14f0f 38 fields · synced Jun 8, 2026