PL8
55 catalogue numbers from Support screws, ø2.5mm, listed by Citieffe SRL, Italy, under Plate, Fixation, Bone. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
55catalogue numbers in this listing
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 | Citieffe SRL, Italy |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K180150 |
| Record published | 2018-09-01 |
| Record revised | 2022-09-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Support screws, ø2.5mm | In distribution | |
| Cortical screw ø2.5mm L20mm | In distribution | |
| Kirschner wire, ø1.2x120mm | In distribution | |
| Wrist reconstruction plate, XL right | In distribution | |
| Guide block, right | In distribution | |
| Cortical screw ø2.5mm L12mm | In distribution | |
| Drill bit, ø2.5x150mm | In distribution | |
| Wrist reconstruction plate, M left | In distribution | |
| Cortical screw ø2.5mm L28mm | In distribution | |
| Bone forceps | In distribution | |
| Locking screw ø2.5mm L20mm | In distribution | |
| Cortical screw ø2.5mm L26mm | In distribution | |
| Locking screw ø2.5mm L28mm | In distribution | |
| Locking screw ø2.5mm L16mm | In distribution | |
| Screwdriver, T8 | In distribution | |
| Reduction forceps ball-spike | In distribution | |
| Cortical screw ø2.5mm L18mm | In distribution | |
| Wrist reconstruction plate, S right | In distribution | |
| Drill bit, ø1.9x150mm | In distribution | |
| Locking screw ø2.5mm L24mm | In distribution | |
| Template – wrist, L-XL | In distribution | |
| Kirschner wire, ø1.2x120mm | In distribution | |
| Drill bit, ø2.5x150mm | In distribution | |
| Sharp hook | In distribution | |
| Wrist reconstruction plate, L right | In distribution | |
| Drill bit, ø1.9x150mm | In distribution | |
| Cortical screw ø2.5mm L22mm | In distribution | |
| Wrist instrument box, empty | In distribution | |
| Locking screw ø2.5mm L26mm | In distribution | |
| Locking screw ø2.5mm L30mm | In distribution | |
| Cortical screw ø2.5mm L8mm | In distribution | |
| Cortical screw ø2.5mm L10mm | In distribution | |
| Cortical screw ø2.5mm L24mm | In distribution | |
| Depth gauge, ø2.5mm | In distribution | |
| Locking screw ø2.5mm L12mm | In distribution | |
| Locking screw ø2.5mm L22mm | In distribution | |
| Locking screw ø2.5mm L10mm | In distribution | |
| Raspatorium | In distribution | |
| Wrist reconstruction plate, L left | In distribution | |
| Reduction forceps sharp | In distribution | |
| Wrist reconstruction plate, S left | In distribution | |
| Guide block, left | In distribution | |
| Cortical screw ø2.5mm L30mm | In distribution | |
| Drill guide, ø2.5mm | In distribution | |
| Cortical screw ø2.5mm L16mm | In distribution | |
| Cortical screw ø2.5mm L14mm | In distribution | |
| Hohmann retractor | In distribution | |
| Screwdriver shaft, T8 | In distribution | |
| Wrist reconstruction plate, M right | In distribution | |
| Locking screw ø2.5mm L14mm | In distribution | |
| Torque limiting handle, screws ø2.5mm | In distribution | |
| Wrist reconstruction plate, XL left | In distribution | |
| Locking screw ø2.5mm L18mm | In distribution | |
| Locking screw ø2.5mm L8mm | In distribution | |
| Template – wrist, S-M | 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
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.