Endoskeletal Components
30mm Transfemoral Kit w/ Rotatable Pyramid Adapter w/ Pin-Lock Hole, Ti
6manufacturers in China registered for this device type
102catalogue numbers in this listing
Who Else Makes It
Concentrated in Fujian (2), Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Baoji Shengtaike Industry & Trade Co., Ltd. | Baoji | Shanxi | Contract manufacturer | 7 |
| Orthotech Rehabilitation Co., Ltd. | Xiamen | Fujian | Manufacturer | 26 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Huae Trade Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 10 |
| T&L (Jiaxing) Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 4 |
| Fujian Guozi Rehabilitation Medical Co., Ltd. | Fuzhou | Fujian | Manufacturer | 2 |
Record
| Listed by | College Park Industries, United States |
|---|---|
| FDA product code | IQO |
| Device type | Device, Prosthesis Alignment |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4HFK 14 | In distribution | |
| 4HPH T | In distribution | |
| 4HPA AO T | In distribution | |
| CP TCS P | In distribution | |
| 4HFK 16 | In distribution | |
| 2530K PA | In distribution | |
| TC S 34 | In distribution | |
| 4HLP RG A | In distribution | |
| TI TFK PHR | In distribution | |
| HD TFK PA | In distribution | |
| BESS TTK PA | In distribution | |
| TC T 22 | In distribution | |
| 4HTP 10 AHR T | In distribution | |
| 3PA AHR T | In distribution | |
| 3PA RR T | In distribution | |
| LP TH | In distribution | |
| TA WT250 30 | In distribution | |
| 4HLP AP | In distribution | |
| TC T 2530 | In distribution | |
| TC T 25 | In distribution | |
| 2530K PAP | In distribution | |
| 4HTP 10 RR S | In distribution | |
| TR T | In distribution | |
| 22K PAP | In distribution | |
| TA WT430 30 | In distribution | |
| 4HLP ST A | In distribution | |
| 4HLP RHD S | In distribution | |
| 3PA R | In distribution | |
| 25K PAP | In distribution | |
| 4PA RR T | In distribution | |
| TA T250 30 | In distribution | |
| TA S430 34 | In distribution | |
| 4PA RR S | In distribution | |
| 4HPR T | In distribution | |
| 4HPA TP | In distribution | |
| TC T 30 | In distribution | |
| TA S250 34 | In distribution | |
| CP SSET | In distribution | |
| SS TTK PA | In distribution | |
| CP TCS | In distribution | |
| LPFK 10 | In distribution | |
| 4HPR TP | In distribution | |
| TA T300 2530 | In distribution | |
| TA T300 25 | In distribution | |
| 4HPRR TP | In distribution | |
| 4HLP RTG A | In distribution | |
| SS TFK PA | In distribution | |
| DR T45 | In distribution | |
| TA T430 30 | In distribution | |
| 4HTP 10 A | In distribution | |
| 4HPAR TP | In distribution | |
| 4HFK 22 | In distribution | |
| HD TTK PA | In distribution | |
| CP SSET P | In distribution | |
| 4PA R | In distribution | |
| 4HPA S | In distribution | |
| 4HPRR T | In distribution | |
| 3PA RR S | In distribution | |
| CP FPCS | In distribution | |
| 4HLP A | In distribution | |
| 4HPA T | In distribution | |
| 4HFK 25 | In distribution | |
| 4HPR S | In distribution | |
| CP T HDL 250 | In distribution | |
| CSSS TTK PA | In distribution | |
| TA T300 22 | In distribution | |
| LPFK 6 | In distribution | |
| DR T35 | In distribution | |
| 4HPA DO T | In distribution | |
| 4ESAH T | In distribution | |
| LP A | In distribution | |
| 4HLP RHD T | In distribution | |
| TI TTK PA | In distribution | |
| LPFK 6P | In distribution | |
| BESS TFK PA | In distribution | |
| TA S250 30 | In distribution | |
| LC | In distribution | |
| TC S 30 | In distribution | |
| TAH T | In distribution | |
| 4HTP 10 AHR S | In distribution | |
| 3PA AHR S | In distribution | |
| 4ESAH S | In distribution | |
| TI TFK PA | In distribution | |
| DR T60 | In distribution | |
| TA S430 30 | In distribution | |
| TI TFK PAH | In distribution | |
| 4HPHR T | In distribution | |
| 4HLP RT A | In distribution | |
| TI TTK PAR | In distribution | |
| TI TTK PHR | In distribution | |
| 4HTP 10 RR T | In distribution | |
| DR T75 | In distribution | |
| CP T HDL 430 | In distribution | |
| TI TTK PAH | In distribution | |
| TR S | In distribution | |
| TAH S | In distribution | |
| 4PA AHR S | In distribution | |
| TI TFK PAR | In distribution | |
| CSSS TFK PA | In distribution | |
| 4HFK 14P | In distribution | |
| 4PA AHR T | In distribution | |
| 4HPAR T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Juzo SoftCompress | Julius Zorn, Inc. | 19 |
| Osseointegration Prosthetic Limb | Osseointegration International Pty Ltd | 13 |
| C100 Cylindrical Shuttle Lock | College Park Industries | 13 |
| Juzo Night | Julius Zorn, Inc. | 12 |
| Torsion Adapter | College Park Industries | 6 |
| LA Liner, Pin, Tapered, 9mm, Medium | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 6mm, Large | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 3mm, Medium+ | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 9mm, Medium | Silipos Holding LLC | 2 |
| LA Liner, Pin, Uniform, 3mm, Large+ | Silipos Holding LLC | 2 |
| LA Liner, Pin, Tapered, 3mm, Medium+ | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Tapered, 3mm, Medium+ | Silipos Holding LLC | 2 |
Showing 12 of 38. All products under Device, Prosthesis Alignment
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.