Implant Selection Device

FDA UDI

Class II (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: Implant Selection Device FDA UDI
Generic Name: Surgical depth gauge, reusable FDA UDI
Device Name: Reusable surgical measurement instrument used when determining the size of the CurvaFix IM Implant to be used in a pelvic fixation procedure. FDA UDI
Model / Reference: ISD-001 FDA UDI
Description: Reusable surgical measurement instrument used when determining the size of the CurvaFix IM Implant to be used in a pelvic fixation procedure. FDA UDI

Identifiers

Catalog Number: ISD-001 FDA UDI
Primary DI / UDI-DI: 10855068008331 FDA UDI
FDA Product Code: HWC FDA UDI
HSB FDA UDI
HTJ FDA UDI
GMDN Term: Surgical depth gauge, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3020 FDA UDI
888.4300 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

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Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical depth gauge, reusable

Implant Selection Device by Curvafix Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical depth gauge, reusable.

Depth Gauge — I.T.S. GmbH · Class I
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FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
Trigen — Smith & Nephew, Inc. · Class I
HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · 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 II	Pending data

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Manufacturer

Manufacturer: Curvafix Inc

Sources (1)

FDA UDI 829588ec-15a1-4c79-bd68-021c339d20f8 35 fields · synced May 30, 2026