Osseoflex PC Pre-Curved Bone Tamp 10ga

FDA UDI

Class I (US FDA UDI)

by Osseon, LLC

Identity

Trade Name: Osseoflex PC Pre-Curved Bone Tamp 10ga FDA UDI
Generic Name: Bone access channel kit FDA UDI
Device Name: The Osseoflex PC Pre-Curved Bone Tamp is a mechanical device used to disrupt cancellous bone by channeling through the bone creating a void within a vertebral body. The Osseoflex PC Pre-Curved Bone Tamp can be utilized for multiple level vertebral body access. The channel can be used to introduce an appropriately sized Osseon inflatable bone tamp. FDA UDI
Model / Reference: PC-0270 FDA UDI
Description: The Osseoflex PC Pre-Curved Bone Tamp is a mechanical device used to disrupt cancellous bone by channeling through the bone creating a void within a vertebral body. The Osseoflex PC Pre-Curved Bone Tamp can be utilized for multiple level vertebral body access. The channel can be used to introduce an appropriately sized Osseon inflatable bone tamp. FDA UDI

Identifiers

Primary DI / UDI-DI: B330PC02700 FDA UDI
FDA Product Code: HXG FDA UDI
GMDN Term: Bone access channel kit 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 10 Gauge FDA UDI

Category: Bone access channel kit

Osseoflex PC Pre-Curved Bone Tamp 10ga by Osseon, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Osseon, LLC

Sources (1)

FDA UDI 631812f3-d64d-40c9-91f7-26886f9b20a5 35 fields · synced Jun 8, 2026