Identity
- Trade Name
- SURFIX FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head. FDA UDI
- Model / Reference
- 286212ND FDA UDI
- Description
- Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head. FDA UDI
Identifiers
- Catalog Number
- 286212ND FDA UDI
- Primary DI / UDI-DI
- 10381780049548 FDA UDI
- 510(k) Number
- K093163 FDA UDI
- FDA Product Code
- LXT FDA UDIHRS 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
Yes
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
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Surfix by Newdeal Sas — 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
- Monster Screw System — Paragon 28 · Class II
- TMS SYSTEM — BIOMET MICROFIXATION, INC · Class II
Cleared under the same submission
K093163 also covers:
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
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 705270ff-2de3-4c97-ab87-8bb86ac96792 39 fields · synced Jun 1, 2026