Penfield Elevator
A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made…
A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
Record
| Listed by | N S Surgical Company |
|---|---|
| FDA product code | HTE |
| Device type | Elevator |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2023-04-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization, Ultraviolet Light |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 19 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08-036-03 | Length 19 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Instruments | Life Instrument Corp. | 383 |
| General Instruments | Alphatec Spine, Inc. | 326 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 209 |
| Battalion | Alphatec Spine, Inc. | 152 |
| IdentiTi | Alphatec Spine, Inc. | 110 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 103 |
| Orthomed | Ortho-MED, Inc. | 100 |
| Tecomet | Tecomet, Inc. | 88 |
| Innomed, Inc. | Innomed, Inc. | 85 |
| General Instrument | Alphatec Spine, Inc. | 85 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 71 |
| Elmed | Elmed, Inc. | 67 |
Showing 12 of 246. All products under Elevator
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.