Osseoflex®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Osseoflex® FDA UDI
Generic Name: Inflatable bone tamp FDA UDI
Model / Reference: 00884450327937 FDA UDI

Identifiers

Catalog Number: OT-0224/A FDA UDI
Primary DI / UDI-DI: 00884450327937 FDA UDI
FDA Product Code: NDN FDA UDI
GMDN Term: Inflatable bone tamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Inflatable bone tamp

A medical device used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus] with an inflatable balloon at the distal end. Commonly used for kyphoplasty.

Similar devices

Also classified as Inflatable bone tamp.

KYPHON Express II Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
SpineKure Kyphoplasty System — Hanchang Co., Ltd. · Class II
MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD. · Class II
SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II
KYPHON Xpander™ Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
KYPHON® Express™ Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Osseoflex SB Steerable Balloon (8ga/2ml) — Osseon, LLC · Class II
Osseoflex SB Steerable Balloon ( 10 ga/ 4ml) — Osseon, LLC · Class II

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: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 4fb25e8d-15b2-432b-83be-0972c7c79a8e 34 fields · synced Jul 11, 2026