Snap-OFF
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-BOP plates. They are available in different diameters and sizes. They exist in different…
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-BOP plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device.The distal end of the snap-off screw has a smooth tip to protect tissues.
22manufacturers in China registered for this device type
40catalogue 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) | K093781 |
| Record published | 2017-10-09 |
| Record revised | 2024-02-19 (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 |
| 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 |
|---|---|---|
| 117034SND | 2.7mm diam. x 34mm length | In distribution |
| 117114ND | 3.0mm diam. x 14mm length | In distribution |
| 117020ND | 2.7mm diam. x 20mm length | In distribution |
| 117124SND | 3.0mm diam. x 24mm length | In distribution |
| 117116SND | 3.0mm diam. x 16mm length | In distribution |
| 117110SND | 3.0mm diam. x 10mm length | In distribution |
| 117014SND | 2.7mm diam. x 14mm length | In distribution |
| 117028ND | 2.7mm diam. x 28mm length | In distribution |
| 117126SND | 3.0mm diam. x 26mm length | In distribution |
| 117116ND | 3.0mm diam. x 16mm length | In distribution |
| 117014ND | 2.7mm diam. x 14mm length | In distribution |
| 117032ND | 2.7mm diam. x 32mm length | In distribution |
| 117024ND | 2.7mm diam. x 24mm length | In distribution |
| 117020SND | 2.7mm diam. x 20mm length | In distribution |
| 117012SND | 2.7mm diam. x 12mm length | In distribution |
| 117026SND | 2.7mm diam. x 26mm length | In distribution |
| 117112SND | 3.0mm diam. x 12mm length | In distribution |
| 117122SND | 3.0mm diam. x 22mm length | In distribution |
| 117034ND | 2.7mm diam. x 34mm length | In distribution |
| 117012ND | 2.7mm diam. x 12mm length | In distribution |
| 117028SND | 2.7mm diam. x 28mm length | In distribution |
| 117018ND | 2.7mm diam. x 18mm length | In distribution |
| 117018SND | 2.7mm diam. x 18mm length | In distribution |
| 117112ND | 3.0mm diam. x 12mm length | In distribution |
| 117010SND | 2.7mm diam. x 10mm length | In distribution |
| 117110ND | 3.0mm diam. x 10mm length | In distribution |
| 117024SND | 2.7mm diam. x 24mm length | In distribution |
| 117010ND | 2.7mm diam. x 10mm length | In distribution |
| 117118ND | 3.0mm diam. x 18mm length | In distribution |
| 117026ND | 2.7mm diam. x 26mm length | In distribution |
| 117016SND | 2.7mm diam. x 16mm length | In distribution |
| 117030SND | 2.7mm diam. x 30mm length | In distribution |
| 117032SND | 2.7mm diam. x 32mm length | In distribution |
| 117022SND | 2.7mm diam. x 22mm length | In distribution |
| 117016ND | 2.7mm diam. x 16mm length | In distribution |
| 117022ND | 2.7mm diam. x 22mm length | In distribution |
| 117118SND | 3.0mm diam. x 18mm length | In distribution |
| 117114SND | 3.0mm diam. x 14mm length | In distribution |
| 117120SND | 3.0mm diam. x 20mm length | In distribution |
| 117030ND | 2.7mm diam. x 30mm 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
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.