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OrthoSolutions 'System26' Bone Screws

FDA UDI

Class II (US FDA UDI)

by Ortho Solutions Holdings Limited

Identity

Trade Name
OrthoSolutions 'System26' Bone Screws FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
8.0MM X 70MM HEADED CANNULATED SCREW 30MM THREAD FDA UDI
Model / Reference
OS920070-NS FDA UDI
Description
8.0MM X 70MM HEADED CANNULATED SCREW 30MM THREAD FDA UDI

Identifiers

Catalog Number
OS920070-NS FDA UDI
Primary DI / UDI-DI
05055662951509 FDA UDI
510(k) Number
K163489 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

OrthoSolutions 'System26' Bone Screws by Ortho Solutions Holdings Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K163489 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Solutions Holdings Limited

Sources (1)

  • FDA UDI 5a3db021-408a-4d6b-9a7b-f2e6ec9b0932 37 fields · synced May 31, 2026