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Osseoflex SB Steerable Balloon (8ga/ 4ml)

FDA UDI

Class II (US FDA UDI)

by Osseon, LLC

Identity

Trade Name
Osseoflex SB Steerable Balloon (8ga/ 4ml) FDA UDI
Generic Name
Inflatable bone tamp FDA UDI
Device Name
The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN+ steerable needle to fill the previously created void(s). An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images. FDA UDI
Model / Reference
OF-0005 FDA UDI
Description
The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN+ steerable needle to fill the previously created void(s). An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images. FDA UDI

Identifiers

Primary DI / UDI-DI
B330OF00050 FDA UDI
FDA Product Code
NDN FDA UDI
HRX FDA UDI
GMDN Term
Inflatable bone tamp FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3027 FDA UDI
888.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 9 Gauge FDA UDI
Total Volume — 4 Milliliter FDA UDI

Category: Inflatable bone tamp

Osseoflex SB Steerable Balloon (8ga/ 4ml) by Osseon, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inflatable bone tamp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osseon, LLC

Sources (1)

  • FDA UDI 79a1a28f-6aee-4da1-95f8-87a5ecbd65c8 35 fields · synced May 30, 2026