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Squale

FDA UDI

Class II (US FDA UDI)

by Implanet

Identity

Trade Name
SQUALE FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Pusher FDA UDI
Model / Reference
580001 FDA UDI
Description
Pusher FDA UDI

Identifiers

Catalog Number
580001 FDA UDI
Primary DI / UDI-DI
03607505800011 FDA UDI
510(k) Number
K230026 FDA UDI
FDA Product Code
ODP FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

Squale by Implanet — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Cleared under the same submission

K230026 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Implanet

Sources (1)

  • FDA UDI b150e2a4-8b0d-4949-afb7-d436b8d40a9d 35 fields · synced Jun 8, 2026