Bold
The BOLD SCREW is a cannulated compression screw made of a Titanium alloy. Its design includes a long non-threaded shaft, allowing optimal compression, and a self-tapping screw tip. These…
The BOLD SCREW is a cannulated compression screw made of a Titanium alloy. Its design includes a long non-threaded shaft, allowing optimal compression, and a self-tapping screw tip. These features enable its use in small bone fixation and its specific design allows its use in the foot. Screws come in lengths of 10-34 mm.
31manufacturers in China registered for this device type
37catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Newdeal Sas, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K011262 |
| 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 |
|---|---|---|
| 111022ND | 3.0mm diam. x 22mm length | In distribution |
| 131032SND | 3.7mm diam. x 32mm length | In distribution |
| 131018SND | 3.7mm diam. x 18mm length | In distribution |
| 111012SND | 3.0mm diam. x 12mm length | In distribution |
| 131034SND | 3.7mm diam. x 34mm length | In distribution |
| 111014SND | 3.0mm diam. x 14mm length | In distribution |
| 111020ND | 3.0mm diam. x 20mm length | In distribution |
| 131030SND | 3.7mm diam. x 30mm length | In distribution |
| 111022SND | 3.0mm diam. x 22mm length | In distribution |
| 111026ND | 3.0mm diam. x 26mm length | In distribution |
| 111034SND | 3.0mm diam. x 34mm length | In distribution |
| 111028SND | 3.0mm diam. x 28mm length | In distribution |
| 131016SND | 3.7mm diam. x 16mm length | In distribution |
| 111030ND | 3.0mm diam. x 30mm length | In distribution |
| 111010ND | 3.0mm diam. x 10mm length | In distribution |
| 131022SND | 3.7mm diam. x 22mm length | In distribution |
| 131028SND | 3.7mm diam. x 28mm length | In distribution |
| 111010SND | 3.0mm diam. x 10mm length | In distribution |
| 131026SND | 3.7mm diam. x 26mm length | In distribution |
| 111012ND | 3.0mm diam. x 12mm length | In distribution |
| 111016ND | 3.0mm diam. x 16mm length | In distribution |
| 111014ND | 3.0mm diam. x 14mm length | In distribution |
| 111032SND | 3.0mm diam. x 32mm length | In distribution |
| 111030SND | 3.0mm diam. x 30mm length | In distribution |
| 111034ND | 3.0mm diam. x 34mm length | In distribution |
| 111024ND | 3.0mm diam. x 24mm length | In distribution |
| 111028ND | 3.0mm diam. x 28mm length | In distribution |
| 131020SND | 3.7mm diam. x 20mm length | In distribution |
| 111032ND | 3.0mm diam. x 32mm length | In distribution |
| 111024SND | 3.0mm diam. x 24mm length | In distribution |
| 111018SND | 3.0mm diam. x 18mm length | In distribution |
| 111020SND | 3.0mm diam. x 20mm length | In distribution |
| 131024SND | 3.7mm diam. x 24mm length | In distribution |
| 131014SND | 3.7mm diam. x 14mm length | In distribution |
| 111026SND | 3.0mm diam. x 26mm length | In distribution |
| 111018ND | 3.0mm diam. x 18mm length | In distribution |
| 111016SND | 3.0mm diam. x 16mm length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071639 | 2007-07-09 |
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.