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Flow-Screw™

FDA UDI

Class II (US FDA UDI)

by Flow-Fx, LLC

Identity

Trade Name
Flow-Screw™ FDA UDI
Generic Name
Orthopaedic bone bolt FDA UDI
Device Name
5.5mm Bolt Long FDA UDI
Model / Reference
102-18-11 FDA UDI
Description
5.5mm Bolt Long FDA UDI

Identifiers

Catalog Number
102-18-11 FDA UDI
Primary DI / UDI-DI
B26710218110 FDA UDI
510(k) Number
K142776 FDA UDI
FDA Product Code
HTN FDA UDI
GMDN Term
Orthopaedic bone bolt 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone bolt

Flow-Screw™ by Flow-Fx, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone bolt.

Cleared under the same submission

K142776 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flow-Fx, LLC

Sources (1)

  • FDA UDI c58b3634-f9a6-467b-a395-27a227f47179 35 fields · synced May 30, 2026