Gaudi
The listed Proximal Humerus Plate is a plate component of the Gaudi Proximal Humerus Plate system. The FDA summary describes proximal humeral plates and bone screws shaped for the proximal…
The listed Proximal Humerus Plate is a plate component of the Gaudi Proximal Humerus Plate system. The FDA summary describes proximal humeral plates and bone screws shaped for the proximal humerus.
The FDA indication names fractures, fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.
Listed Item
Fixation screw for Gaudi Proximal Humerus Plate, 3.5 diameter X 14mm length
Plate System
The filing describes long and short plate sizes with left and right configurations. It also lists bone screws in two diameters, 3.5 mm and 4 mm, and 23 lengths from 14 mm to 52 mm.
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 | Netbiologics LLC, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K241296 |
| Record published | 2025-05-14 |
| Record revised | 2025-11-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 14 mm; outer diameter 3.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | Length 14 mm | In distribution |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution | |
| Proximal Humerus Plate Fixation Screw | In distribution |
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 |
|---|---|
| K241296 | 2024-07-23 |
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.