Surfix Alpha
Titanium alloy Newdeal sterile angular locking system fixation consists of variable angle screws and washers. This system is available in different sizes. The osteosynthesis screws are…
Titanium alloy Newdeal sterile angular locking system fixation consists of variable angle screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
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 | Newdeal Sas, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K073375 |
| Record published | 2017-10-09 |
| Record revised | 2024-02-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dry place. |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 295314SND | 3.5mm diam. x 14mm length | In distribution |
| 295340SND | 3.5mm diam. x 40mm length | In distribution |
| 295348SND | 3.5mm diam. x 48mm length | In distribution |
| 295326SND | 3.5mm diam. x 26mm length | In distribution |
| 295322SND | 3.5mm diam. x 22mm length | In distribution |
| 195300SND | 3.5mm diam. | In distribution |
| 295344SND | 3.5mm diam. x 44mm length | In distribution |
| 295312SND | 3.5mm diam. x 12mm length | In distribution |
| 295316SND | 3.5mm diam. x 16mm length | In distribution |
| 295336SND | 3.5mm diam. x 36mm length | In distribution |
| 295324SND | 3.5mm diam. x 24mm length | In distribution |
| 295310SND | 3.5mm diam. x 10mm length | In distribution |
| 295320SND | 3.5mm diam. x 20mm length | In distribution |
| 295334SND | 3.5mm diam. x 34mm length | In distribution |
| 295318SND | 3.5mm diam. x 18mm length | In distribution |
| 295338SND | 3.5mm diam. x 38mm length | In distribution |
| 295350SND | 3.5mm diam. x 50mm length | In distribution |
| 295330SND | 3.5mm diam. x 30mm length | In distribution |
| 295332SND | 3.5mm diam. x 32mm length | In distribution |
| 295328SND | 3.5mm diam. x 28mm length | 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 |
|---|---|
| K093914 | 2011-04-14 |
| K093781 | 2010-01-22 |
| K083154 | 2009-07-10 |
| K091609 | 2009-06-30 |
| K073375 | 2008-02-21 |
| K070447 | 2007-03-29 |
| K063831 | 2007-02-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2022-01-04 | Class II | Process control | The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw | 8 units (US) |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 |
| 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 |
| 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 |
| 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 |
| 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 |
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.