| Primary Device ID | B330OF00050 |
| NIH Device Record Key | 79a1a28f-6aee-4da1-95f8-87a5ecbd65c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osseoflex SB Steerable Balloon (8ga/ 4ml) |
| Version Model Number | OF-0005 |
| Company DUNS | 079316474 |
| Company Name | OSSEON LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (877) 567-7366 |
| customerservice@osseon.com | |
| Phone | (877) 567-7366 |
| customerservice@osseon.com |
| Needle Gauge | 9 Gauge |
| Total Volume | 4 Milliliter |
| Needle Gauge | 9 Gauge |
| Total Volume | 4 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B330OF00050 [Primary] |
| NDN | Cement, Bone, Vertebroplasty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
| B330OF00050 - Osseoflex SB Steerable Balloon (8ga/ 4ml) | 2018-03-29The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fractu |
| B330OF00050 - Osseoflex SB Steerable Balloon (8ga/ 4ml) | 2018-03-29 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, ther |
| B330OF02220 - Osseoflex SB Steerable Balloon (10ga/2ml) | 2018-03-29 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, ther |
| B330OF02240 - Osseoflex SB Steerable Balloon ( 10 ga/ 4ml) | 2018-03-29 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, ther |
| B330OF03480 - Osseoflex CD-H | 2018-03-29 Osseoflex® CD-H Hydraulic Cement Delivery system is a bone cement delivery device designed to allow the physician to keep a saf |
| B330OF82220 - Osseoflex SB Steerable Balloon (8ga/2ml) | 2018-03-29 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, ther |
| B330OT02220 - Osseoflex SB Straight Balloon (10ga/2ml) | 2018-03-29 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, ther |
| B330OT02240 - Osseoflex SB Straight Balloon (10ga/4ml) | 2018-03-29 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, ther |
| B330PC02700 - Osseoflex PC Pre-Curved Bone Tamp 10ga | 2018-03-29 The Osseoflex PC Pre-Curved Bone Tamp is a mechanical device used to disrupt cancellous bone by channeling through the bone crea |