Identity
- Trade Name
- Fuse ULTRA Foot plating System FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- 60 L AO QC Drill Bits FDA UDI
- Model / Reference
- OS200160L FDA UDI
- Description
- 60 L AO QC Drill Bits FDA UDI
Identifiers
- Catalog Number
- OS200160L FDA UDI
- Primary DI / UDI-DI
- B565OS200160L1 FDA UDI
- 510(k) Number
- K141784 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable 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
No
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
Yes
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 surgical procedure kit, non-medicated, reusable
Fuse ULTRA Foot plating System by CPM Medical Consultants, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
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- Spine Instruments — Medacta International · Class I
- Knee Instruments — Medacta International · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- General Instruments — ORTHOPEDIATRICS CORP. · Class I
- Hip Instruments — Medacta International · Class I
- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT — FX SOLUTIONS · Class I
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 0bc2f5a3-0d86-4485-8f4b-b990dec29a48 36 fields · synced Jun 8, 2026