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Hex Button

FDA UDI

Class II (US FDA UDI)

by Pioneer Surgical Technology, Inc.

Identity

Trade Name
Hex Button FDA UDI
Generic Name
Implantable orthopaedic/craniofacial device connection screw FDA UDI
Device Name
Hex Button 2.5mm FDA UDI
Model / Reference
400-782 FDA UDI
Description
Hex Button 2.5mm FDA UDI

Identifiers

Catalog Number
2232-02-25 FDA UDI
Primary DI / UDI-DI
00846468064006 FDA UDI
510(k) Number
K992617 FDA UDI
FDA Product Code
HTN FDA UDI
GMDN Term
Implantable orthopaedic/craniofacial device connection screw 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Implantable orthopaedic/craniofacial device connection screw

Hex Button by Pioneer Surgical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable orthopaedic/craniofacial device connection screw.

Cleared under the same submission

K992617 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pioneer Surgical Technology, Inc.

Sources (1)

  • FDA UDI 2d22291e-7c05-42dd-ad2f-8bce0df34fd2 36 fields · synced Jun 8, 2026