Identity
- Trade Name
- Fuse ULTRA Foot plating System FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- 3.5 mm Non-Locking Screw 35mm FDA UDI
- Model / Reference
- R421835 FDA UDI
- Description
- 3.5 mm Non-Locking Screw 35mm FDA UDI
Identifiers
- Catalog Number
- R421835 FDA UDI
- Primary DI / UDI-DI
- B565R4218351 FDA UDI
- 510(k) Number
- K141784 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Fuse ULTRA Foot plating System by CPM Medical Consultants, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- CPM Medical Consultants, LLC
Sources (1)
- FDA UDI 460f1b9b-cb6e-4d9b-bbd1-4da4c3261838 36 fields · synced May 31, 2026