UNI CP
The Newdeal sterile Compression Plate consists of an U shaped plate, available in different sizes, and is implanted using Newdeal locking system fixation screws and washers. This system…
The Newdeal sterile Compression Plate consists of an U shaped plate, available in different sizes, and is implanted using Newdeal locking system fixation screws and washers. This system includes as many fixation screws and washers as threaded lipped sockets on the plate. 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.
22manufacturers in China registered for this device type
12catalogue numbers in this listing
7510(k) clearances naming this product code
5recalls on this 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 | Newdeal Sas, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K070447 |
| Record published | 2017-10-09 |
| Record revised | 2025-11-20 (version 9) |
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 |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store in dry place. |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 330220SND | 31mm length x 8.3mm width x 20mm interaxis | In distribution |
| 330217SND | 28mm length x 8.3mm width x 17mm interaxis | In distribution |
| 330023SND | 27.66mm width x 32.33mm length | In distribution |
| 330025SND | 29.66mm width x 34.83mm length | In distribution |
| 330225SND | 36mm length x 8.3mm width x 25mm interaxis | In distribution |
| 330430SND | 38.3mm length x 17.3mm width x 30mm interaxis | In distribution |
| 330425SND | 33.3mm length x 17.3mm width x 25mm interaxis | In distribution |
| 330230SND | 41mm length x 8.3mm width x 30mm interaxis | In distribution |
| 330021SND | 25.66mm width x 29.83mm length | In distribution |
| 330420SND | 28.3mm length x 17.3mm width x 20mm interaxis | In distribution |
| 330030SND | 17.3mm width x 38.65mm length | In distribution |
| UNICP2SET | 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 |
|---|---|
| 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
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Newdeal Sas | 510(k) number | 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 | |
| Newdeal Sas | 510(k) number | 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 | |
| Newdeal Sas | 510(k) number | 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 | |
| Newdeal Sas | 510(k) number | 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 | |
| Newdeal Sas | 510(k) number | 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 | |
| Integra Lifesciences Corporation | 510(k) number | 2010-11-18 | Not classified | Other | Integra LifeSciences Corporation has decided to initiate a voluntary recall of the Uni-Comp Kits due to inaccurate information relative to the recommended sterilization parameters described in the products Instructions for Use (IFU). The s | Sixty seven (67) Kits | 2011-11-18 |
| Integra Lifesciences Corporation | 510(k) number | 2008-09-30 | Not classified | Nonconforming Material/Component | Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate | 90 | 2009-05-11 |
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.