Construct® Ankle Fusion Plate System
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling…
Compression Screw is used with the Construct® Ankle Fusion Plate System. The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
22manufacturers in China registered for this device type
40catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K100176 |
| Record published | 2017-10-09 |
| Record revised | 2024-02-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSS6532CT | 1.401 in L x.256 in dia | Withdrawn |
| AFPL09RT | 4.62mmL X.197mm w | Withdrawn |
| PSS4540LT | 1.715 in L x.177 in dia | Withdrawn |
| PSS6540CT | 1.716 in L x.256 in dia | Withdrawn |
| PSS4560LT | 2.502 in L x.177 in dia | Withdrawn |
| PSS4550CT | 2.110 in L x.177 in dia | Withdrawn |
| AFPL09LT | 4.62mmL X.247mm w | Withdrawn |
| PSS6550CT | 2.110 in L x.256 in dia | Withdrawn |
| PSS6538CT | 1.637 in L x.256 in dia | Withdrawn |
| PSS6524LT | 1.105 in L x.256 in dia | Withdrawn |
| PSS4520LT | .927 in L x.177 in dia | Withdrawn |
| PSS6526LT | 1.184 in L x.256 in dia | Withdrawn |
| PSS4526CT | 1.165 in L x.177 in dia | Withdrawn |
| PSS6528LT | 1.262 in L x.256 in dia | Withdrawn |
| PSS4520CT | .928 in L x.177 in dia | Withdrawn |
| PSS4580CT | 3.291 in L x.177 in dia | Withdrawn |
| PSS4560CT | 2.503 in L x.177 in dia | Withdrawn |
| PSS6530CT | 1.322 in L x.256 in dia | Withdrawn |
| PSS4514LT | .691 in L x.177 in dia | Withdrawn |
| PSS4524CT | 1.086 in L x.177 in dia | Withdrawn |
| PSS4534CT | 1.480 in L x.177 in dia | Withdrawn |
| PSS6545LT | 1.932 in L x.256 in dia | Withdrawn |
| PSS6530LT | 1.341 in L x.256 in dia | Withdrawn |
| PSS4570LT | 2.896 in L x.177 in dia | Withdrawn |
| PSS4555LT | 2.305 in L x.177 in dia | Withdrawn |
| PSS4524LT | 1.085 in L x.177 in dia | Withdrawn |
| PSS4575CT | 3.094 in L x.177 in dia | Withdrawn |
| PSS6560CT | 2.503 in L x.256 in dia | Withdrawn |
| PSS6570LT | 2.916 in L x.256 in dia | Withdrawn |
| PSS6522LT | 1.026 in L x.256 in dia | Withdrawn |
| PSS4516LT | .770 in L x.177 in dia | Withdrawn |
| PSS4518LT | .849 in L x.177 in dia | Withdrawn |
| PSS6580CT | 3.291 in L x.256 in dia | Withdrawn |
| PSS6575CT | 3.094 in L x.256 in dia | Withdrawn |
| PSS6565LT | 2.719 in L x.256 in dia | Withdrawn |
| PSS4565CT | 2.700 in L x.177 in dia | Withdrawn |
| PSS4545LT | 1.912 in L x.177 in dia | Withdrawn |
| PSS4570CT | 2.897 in L x.177 in dia | Withdrawn |
| AFPA09LT | 3.059 in L x 1.415 in W | Withdrawn |
| AFPA07RT | 2.662 in L x 1.345 in W | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121826 | 2013-02-13 |
| K110700 | 2011-12-06 |
| K100502 | 2010-08-02 |
| K100176 | 2010-06-16 |
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.