Surfix

FDA UDI

Class II (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: SURFIX FDA UDI
Generic Name: Orthopaedic bone washer, sterile FDA UDI
Device Name: Titanium alloy sterile washer belonging to the Newdeal locking system fixation. 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: 185300SND FDA UDI
Description: Titanium alloy sterile washer belonging to the Newdeal locking system fixation. 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: 185300SND FDA UDI
Primary DI / UDI-DI: 10381780048497 FDA UDI
510(k) Number: K060474 FDA UDI
K060476 FDA UDI
K063820 FDA UDI
K070241 FDA UDI
K070447 FDA UDI
K073375 FDA UDI
K091609 FDA UDI
K093914 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Orthopaedic bone washer, 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic bone washer, sterile

Surfix by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone washer, sterile.

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TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
FLAT WASHER6.5MM — Biomet Orthopedics, Inc. · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
RONDO' — Citieffe · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II

Cleared under the same submission

K060474 also covers:

K060476 also covers:

K063820 also covers:

K070241 also covers:

K070447 also covers:

K073375 also covers:

K091609 also covers:

K093914 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 75046396-3356-4f23-bf2f-5c846b3f95ae 39 fields · synced Jun 8, 2026