Identity
- Trade Name
- SURFIX FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- The SURFIX Knee Osteotomy System consists of different stainless steel plates for the proximal tibia and the distal femur with a locking system between the threaded sockets of the plates and the lock screws. Their fixation is provided by titanium alloy screws and lock screws available in two versions : cancellous bone screws diameter 6.5 mm and cortical bone screws diameter 4.5 mm. The system fixation creates a single implant/screw unit fixed into the bone thanks to the lock screw. FDA UDI
- Model / Reference
- PTCDND FDA UDI
- Description
- The SURFIX Knee Osteotomy System consists of different stainless steel plates for the proximal tibia and the distal femur with a locking system between the threaded sockets of the plates and the lock screws. Their fixation is provided by titanium alloy screws and lock screws available in two versions : cancellous bone screws diameter 6.5 mm and cortical bone screws diameter 4.5 mm. The system fixation creates a single implant/screw unit fixed into the bone thanks to the lock screw. FDA UDI
Identifiers
- Catalog Number
- PTCDND FDA UDI
- Primary DI / UDI-DI
- 10381780044420 FDA UDI
- 510(k) Number
- K041601 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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
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
Category: Orthopaedic fixation plate, non-bioabsorbable
Surfix by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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- AXSOS — Stryker Corp. · Class II
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Cleared under the same submission
K041601 also covers:
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
- Newdeal Sas
Sources (1)
- FDA UDI 1383e703-e5c8-4824-aa99-c3732f439464 38 fields · synced May 30, 2026