Countersink

FDA UDI

Class I (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: Countersink FDA UDI
Generic Name: Surgical countersink, reusable FDA UDI
Device Name: A manual rotary tool used to enlarge the diameter of the proximal portion of bone canal in preparation for insertion of the CurvaFix Implant. FDA UDI
Model / Reference: CCB-001 FDA UDI
Description: A manual rotary tool used to enlarge the diameter of the proximal portion of bone canal in preparation for insertion of the CurvaFix Implant. FDA UDI

Identifiers

Catalog Number: CCB-001 FDA UDI
Primary DI / UDI-DI: 10855068008218 FDA UDI
FDA Product Code: HWW FDA UDI
HWC FDA UDI
HSB FDA UDI
GMDN Term: Surgical countersink, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
888.3040 FDA UDI
888.3020 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: Surgical countersink, reusable

Countersink by Curvafix Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical countersink, reusable.

WIDE COUNTERSINK DRILL - LONG — BIOTECHNOLOGY INSTITUTE SL · Class I
Zimmer Cannulated Screw System — Pioneer Surgical Technology, Inc. · Class I
Newclip Instruments — NEWCLIP TECHNICS · Class I
COUNTERSINK SMALL FRAG — Biomet Orthopedics, Inc. · Class I
Cortical Counter Sink — I.T.S. GmbH · Class I
EVOS — Smith & Nephew, Inc. · Class I
PERLA ® — Spineart · Class II
DART-FIRE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Curvafix Inc

Sources (1)

FDA UDI 69854c31-ada4-4e1c-8155-fa8a164b49e9 35 fields · synced Jun 1, 2026