Removal Drill, 13.0 mm

FDA UDI

Class I (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: Removal Drill, 13.0 mm FDA UDI
Generic Name: Cannulated surgical drill bit, reusable FDA UDI
Device Name: A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or covering the proximal head of a CurvaFix Implant. FDA UDI
Model / Reference: RKD-002 FDA UDI
Description: A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or covering the proximal head of a CurvaFix Implant. FDA UDI

Identifiers

Catalog Number: RKD-002 FDA UDI
Primary DI / UDI-DI: 10855068008751 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Cannulated surgical drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Cannulated surgical drill bit, reusable

Removal Drill, 13.0 mm by Curvafix Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Curvafix Inc

Sources (1)

FDA UDI 7efaa8f7-2ea3-4b7d-a829-48415a26b6a4 35 fields · synced May 30, 2026