Variable Angle Non-Locking Screw
Implants for orthopedic bone fixation. Also Called a Bone Screw.
31manufacturers in China registered for this device type
133catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Flower Orthopedics Corporation, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K131657 |
| Record published | 2015-09-15 |
| Record revised | 2024-02-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 1.5 to 4 mm; length 6 to 70 mm; height 9 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FBS 432 | Length 32 mm | In distribution |
| FBS 450 | Length 50 mm | In distribution |
| FBS 338 | Length 38 mm | In distribution |
| FBS 006 | Length 6 mm | In distribution |
| FBS 334 | Length 34 mm | In distribution |
| FBS 455 | Length 55 mm | In distribution |
| FBS 414 | Length 14 mm | In distribution |
| FBS 510 | Length 10 mm | In distribution |
| FBS 250 | Length 50 mm | In distribution |
| FBS 506 | Length 6 mm | In distribution |
| FBS 365 | Length 65 mm | In distribution |
| FBS 130 | Length 30 mm | In distribution |
| FBS 332 | Length 32 mm | In distribution |
| FBS 436 | Length 36 mm | In distribution |
| FLS 320 | Length 20 mm | In distribution |
| FBS 316 | Length 16 mm | In distribution |
| FBS 016 | Length 16 mm | In distribution |
| FBS 308 | Length 8 mm | In distribution |
| FBS 216 | Length 16 mm | In distribution |
| FBS 355 | Length 55 mm | In distribution |
| FBS 260 | Length 60 mm | In distribution |
| FLS 336 | Outer Diameter 3.0 mm | In distribution |
| FBS 511 | Length 11 mm | In distribution |
| FBS 220 | Length 20 mm | In distribution |
| FBS 218 | Length 18 mm | In distribution |
| FBS 507 | Length 7 mm | In distribution |
| FBS 114 | Length 14 mm | In distribution |
| FLS 340 | Length 40 mm | In distribution |
| FLS 338 | Length 38 mm | In distribution |
| FBS 010 | Length 10 mm | In distribution |
| FLS 322 | Length 22 mm | In distribution |
| FBS 208 | Length 8 mm | In distribution |
| FBS 030 | Length 30 mm | In distribution |
| FBS 230 | Length 30 mm | In distribution |
| FBS 320 | Length 20 mm | In distribution |
| FBS 518 | Length 18 mm | In distribution |
| FLS 355 | Length 55 mm | In distribution |
| FBS 430 | Length 30 mm | In distribution |
| FBS 122 | Length 22 mm | In distribution |
| FBS 012 | Length 12 mm | In distribution |
| FBS 512 | Length 12 mm | In distribution |
| FBS 270 | Length 70 mm | In distribution |
| FBS 116 | Length 16 mm | In distribution |
| FBS 018 | Length 18 mm | In distribution |
| FBS 120 | Length 20 mm | In distribution |
| FBS 126 | Length 26 mm | In distribution |
| FBS 322 | Length 22 mm | In distribution |
| FBS 245 | Length 45 mm | In distribution |
| FBS 440 | Length 40 mm | In distribution |
| FBS 513 | Length 13 mm | In distribution |
| FBS 236 | Length 36 mm | In distribution |
| FLS 334 | Length 34 mm | In distribution |
| FBS 028 | Length 28 mm | In distribution |
| FBS 324 | Length 24 mm | In distribution |
| FBS 412 | Length 12 mm | In distribution |
| FLS 350 | Length 50 mm | In distribution |
| FBS 426 | Length 26 mm | In distribution |
| FBS 011 | Length 11 mm | In distribution |
| FBS 222 | Length 22 mm | In distribution |
| FBS 312 | Length 12 mm | In distribution |
| FBS 340 | Length 40 mm | In distribution |
| FLS 324 | Length 24 mm | In distribution |
| FLS 314 | Length 14 mm | In distribution |
| FBS 108 | Length 8 mm | In distribution |
| FBS 508 | Length 8 mm | In distribution |
| FBS 310 | Length 10 mm | In distribution |
| FBS 232 | Length 32 mm | In distribution |
| FLS 310 | Length 10 mm | In distribution |
| FBS 350 | Length 50 mm | In distribution |
| FBS 345 | Length 45 mm | In distribution |
| FBS 435 | Length 35 mm | In distribution |
| FBS 434 | Length 34 mm | In distribution |
| FBS 007 | Length 7 mm | In distribution |
| FBS 124 | Length 24 mm | In distribution |
| FLS 316 | Length 16 mm | In distribution |
| FBS 318 | Length 18 mm | In distribution |
| FBS 516 | Length 16 mm | In distribution |
| FBS 416 | Length 16 mm | In distribution |
| FBS 460 | Length 60 mm | In distribution |
| FBS 438 | Length 38 mm | In distribution |
| FBS 013 | Length 13 mm | In distribution |
| FBS 470 | Length 70 mm | In distribution |
| FBS 326 | Length 26 mm | In distribution |
| FBS 106 | Length 6 mm | In distribution |
| FLS 328 | Length 28 mm | In distribution |
| FBS 212 | Length 12 mm | In distribution |
| FBS 265 | Length 65 mm | In distribution |
| FBS 022 | Length 22 mm | In distribution |
| FBS 020 | Length 20 mm | In distribution |
| FBS 410 | Length 10 mm | In distribution |
| FBS 509 | Height 9 mm | In distribution |
| FBS 238 | Length 38 mm | In distribution |
| FBS 418 | Length 18 mm | In distribution |
| FBS 228 | Length 28 mm | In distribution |
| FBS 515 | Length 15 mm | In distribution |
| FBS 514 | Length 14 mm | In distribution |
| FBS 128 | Length 28 mm | In distribution |
| FBS 336 | Length 36 mm | In distribution |
| FBS 465 | Length 65 mm | In distribution |
| FBS 210 | Length 10 mm | In distribution |
| FBS 008 | Length 8 mm | In distribution |
| FBS 234 | Length 34 mm | In distribution |
| FBS 118 | Length 18 mm | In distribution |
| FBS 255 | Length 55 mm | In distribution |
| FBS 224 | Length 24 mm | In distribution |
| FLS 330 | Length 30 mm | In distribution |
| FBS 015 | Length 15 mm | In distribution |
| FBS 420 | Length 20 mm | In distribution |
| FBS 240 | Length 40 mm | In distribution |
| FLS 326 | Length 26 mm | In distribution |
| FBS 445 | Length 45 mm | In distribution |
| FLS 312 | Length 12 mm | In distribution |
| FBS 314 | Length 14 mm | In distribution |
| FLS 332 | Length 32 mm | In distribution |
| FLS 360 | Length 60 mm | In distribution |
| FBS 110 | Length 10 mm | In distribution |
| FBS 424 | Length 24 mm | In distribution |
| FBS 360 | Length 60 mm | In distribution |
| FBS 009 | Length 9 mm | In distribution |
| FBS 370 | Outer Diameter 3.5 mm | In distribution |
| FBS 024 | Length 24 mm | In distribution |
| FBS 214 | Length 14 mm | In distribution |
| FBS 520 | Length 20 mm | In distribution |
| FBS 330 | Length 30 mm | In distribution |
| FBS 226 | Length 26 mm | In distribution |
| FBS 328 | Length 28 mm | In distribution |
| FLS 345 | Length 45 mm | In distribution |
| FBS 422 | Length 22 mm | In distribution |
| FBS 014 | Length 14 mm | In distribution |
| FBS 026 | Length 26 mm | In distribution |
| FBS 112 | Length 12 mm | In distribution |
| FLS 318 | Length 18 mm | In distribution |
| FBS 428 | Length 28 mm | 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 |
|---|---|
| K170687 | 2017-06-06 |
| K132248 | 2013-10-30 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| Flower Orthopedics Corporation DBA Conventus Flower | 510(k) number | 2015-02-16 | Class II | Device Design | Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg. | 901 | 2015-08-06 |
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.