Ponseti® Lite
Ponseti® Lite Short BAR 15° BK/Inserts
3manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (1), Guangdong (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Dongguan Vigor Textile Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Putian Lake Sports Goods Co., Ltd. | Putian | Fujian | Manufacturer | 1 |
Record
| Listed by | MD Orthopaedics, United States |
|---|---|
| FDA product code | ITN |
| Device type | Splint, Denis Brown |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3675 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LITE SHORT BAR 15° BK/INSERTS | In distribution | |
| LITE SHORT BAR 10° BK/INSERTS | In distribution | |
| GEARED QUICK CLIP KIT 10° | In distribution | |
| LITE BAR EXTENSION KIT BK | In distribution | |
| LITE LONG BAR 15° WH/INSERTS | In distribution | |
| LITE BAR EXTENSION KIT WH | In distribution | |
| GEARED QUICK CLIP KIT 15° | In distribution | |
| LITE SHORT BAR 15° WH/INSERTS | In distribution | |
| LITE SHORT BAR 10° WH/INSERTS | In distribution | |
| LITE LONG BAR 10° BK/INSERTS | In distribution | |
| LITE LONG BAR 10° WH/INSERTS | In distribution | |
| LITE LONG BAR 15° BK/INSERTS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dobbs | D-Bar Enterprises, LLC | 14 |
| Ponseti® Plus Abduction Bar | MD Orthopaedics | 13 |
| MD Orthopaedics | MD Orthopaedics | 6 |
| Mitchell Ponseti® Move Bar | MD Orthopaedics | 6 |
| Mitchell Ponseti® Bracing System | MD Orthopaedics | 1 |
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.