Identity
- Trade Name
- ORTHO SOLUTIONS ULTOS PLATING SYSTEM FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use, non-sterile FDA UDI
- Device Name
- AO QC DRILL BIT 2.5/110/85 (GOLD) FDA UDI
- Model / Reference
- OS200125 FDA UDI
- Description
- AO QC DRILL BIT 2.5/110/85 (GOLD) FDA UDI
Identifiers
- Catalog Number
- OS200125 FDA UDI
- Primary DI / UDI-DI
- 05055662931105 FDA UDI
- 510(k) Number
- K141784 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
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: Fluted surgical drill bit, single-use, non-sterile
Ortho Solutions Ultos Plating System by Ortho Solutions Holdings Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fluted surgical drill bit, single-use, non-sterile.
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Cleared under the same submission
K141784 also covers:
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA Foot plating System — CPM Medical Consultants, LLC
- Fuse ULTRA Foot plating System — CPM Medical Consultants, LLC
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 I | Pending data |
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Manufacturer
- Manufacturer
- Ortho Solutions Holdings Limited
Sources (1)
- FDA UDI 221b7506-8b6f-4952-ad0f-b2c5121a6e03 36 fields · synced Jun 1, 2026