Tissue Sleeve, Removal Tool

FDA UDI

Class I (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: Tissue Sleeve, Removal Tool FDA UDI
Generic Name: Orthopaedic implantation sleeve, reusable FDA UDI
Device Name: A hand-held stainless steel tube used during a CurvaFix Implant removal to maintain direct access to the Implant head and protect the patient soft tissue. It also contains three integrated holes around the outside diameter to accept Guide Pins to maintain the sleeve position hands-free. FDA UDI
Model / Reference: RKS-001 FDA UDI
Description: A hand-held stainless steel tube used during a CurvaFix Implant removal to maintain direct access to the Implant head and protect the patient soft tissue. It also contains three integrated holes around the outside diameter to accept Guide Pins to maintain the sleeve position hands-free. FDA UDI

Identifiers

Catalog Number: RKS-001 FDA UDI
Primary DI / UDI-DI: 10855068008768 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic implantation sleeve, 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: Orthopaedic implantation sleeve, reusable

Tissue Sleeve, Removal Tool by Curvafix Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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FITBONE TAA SYSTEM — Orthofix, Inc. · Class II
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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 740067ab-d47b-4a38-8ed2-7e7457d5380e 35 fields · synced May 30, 2026