Kyphoplasty systems
CitreLock Inserter Large
by Acuitive Technologies, Inc.
A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.
Where to buy CitreLock Inserter Large
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CitreLock Inserter Large models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 40-102-0002 | — | Not stated | Available |
FDA clearances
- 510(k) K200725 October 2020
Procedures that use kyphoplasty systems
Frequently asked questions
What is CitreLock Inserter Large used for?
A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.
Who makes CitreLock Inserter Large?
CitreLock Inserter Large is made by Acuitive Technologies, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does CitreLock Inserter Large come in?
The FDA device database does not list sizes for CitreLock Inserter Large. Check the instructions for use or ask a Acuitive Technologies, Inc. representative.
Is CitreLock Inserter Large MRI safe?
The FDA device database entry for CitreLock Inserter Large does not state its MRI safety status. Check the labeling before MRI.
Is CitreLock Inserter Large FDA cleared?
CitreLock Inserter Large is covered by FDA submission K200725.
How do I contact a Acuitive Technologies, Inc. sales representative?
Acuitive Technologies, Inc. has not listed representatives on LA Vascular yet. Visit the Acuitive Technologies, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.