Osseoflex PC Pre-Curved Bone Tamp 10ga
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…
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.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Osseon, LLC, United States |
|---|---|
| FDA product code | HXG |
| Device type | Tamp |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2017-04-27 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Needle gauge 10 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PC-0270 | Needle Gauge 10 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 78 |
| Life Instruments | Life Instrument Corp. | 56 |
| 4WEB Medical | 4WEB Inc. | 35 |
| General Instruments | Alphatec Spine, Inc. | 31 |
| CPT® | Zimmer, Inc. | 30 |
| Novel | Alphatec Spine, Inc. | 29 |
| IdentiTi | Alphatec Spine, Inc. | 29 |
| Tamp | Depuy Spine, Inc. | 27 |
| Tamp | Synthes Gmbh | 21 |
| Boss Instruments | Boss Instruments, Ltd. | 19 |
| Millennium | Avalign Technologies, Inc. | 18 |
| Aesculap | Aesculap AG | 17 |
Showing 12 of 267. All products under Tamp
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.