Soft Tissue Sleeve

FDA UDI

Class I (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: Soft Tissue Sleeve FDA UDI
Generic Name: Orthopaedic implantation sleeve, reusable FDA UDI
Device Name: A hand-held stainless steel tube used during a CurvaFix procedure to maintain direct access to the surgical site, protect the patient soft tissue, and facilitate the acceptance of other orthopaedic instrumentation into the surgical site. FDA UDI
Model / Reference: CTS-001 FDA UDI
Description: A hand-held stainless steel tube used during a CurvaFix procedure to maintain direct access to the surgical site, protect the patient soft tissue, and facilitate the acceptance of other orthopaedic instrumentation into the surgical site. FDA UDI

Identifiers

Catalog Number: CTS-001 FDA UDI
Primary DI / UDI-DI: 10855068008447 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Orthopaedic implantation sleeve, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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Lot / Batch Number

Yes

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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

Soft Tissue 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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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 22589f14-1a72-430a-a0be-295185d48b9e 35 fields · synced Jun 1, 2026