Steerable Guide Sleeve

FDA UDI

Class I (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: Steerable Guide Sleeve FDA UDI
Generic Name: Orthopaedic implantation sleeve, reusable FDA UDI
Device Name: A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation procedure to facilitate the acceptance of a Steerable Guide through it. FDA UDI
Model / Reference: CGS-001 FDA UDI
Description: A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation procedure to facilitate the acceptance of a Steerable Guide through it. FDA UDI

Identifiers

Catalog Number: CGS-001 FDA UDI
Primary DI / UDI-DI: 10855068008225 FDA UDI
FDA Product Code: FZX FDA UDI
HWC FDA UDI
HSB FDA UDI
GMDN Term: Orthopaedic implantation sleeve, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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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

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implantation sleeve, reusable

Steerable Guide Sleeve by Curvafix Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implantation sleeve, reusable.

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gSource — GSOURCE, LLC. · Class I
FITBONE TAA SYSTEM — Orthofix, Inc. · Class II
RIGID SUPRA ENTRY SLEEVE 13MM — Zimmer, Inc. · Class I
Jet-X — Smith & Nephew, Inc. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class I
Salvo® Spine System — Spine Wave, Inc. · Class I
DRILL SLEEVE — Biomet Orthopedics, 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

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Manufacturer

Manufacturer: Curvafix Inc

Sources (1)

FDA UDI 458c6acd-337a-49c8-be09-93b377d4f4a8 35 fields · synced May 30, 2026