Identity
- Trade Name
- Fuse ULTRA FOOT PLATING SYSTEM FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- 1.1 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR FDA UDI
- Model / Reference
- OS2016116 FDA UDI
- Description
- 1.1 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR FDA UDI
Identifiers
- Catalog Number
- OS2016116 FDA UDI
- Primary DI / UDI-DI
- B565OS20161160 FDA UDI
- 510(k) Number
- K141784 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic intraoperative positioning pin, single-use
Fuse ULTRA FOOT PLATING SYSTEM by CPM Medical Consultants, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic intraoperative positioning pin, single-use.
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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
- CPM Medical Consultants, LLC
Sources (1)
- FDA UDI 461b08b5-6a90-4948-b9f2-737dcb69a9ac 36 fields · synced May 30, 2026