Variable Angle Locking Screw
128 catalogue numbers from FRP 208, listed by Flower Orthopedics Corporation, United States, under Screw, Fixation, Bone. 31 manufacturers in China are registered for this product code.
31manufacturers in China registered for this device type
128catalogue 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) | K123562 |
| Record published | 2015-09-15 |
| Record revised | 2024-02-19 (version 4) |
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 2.7 to 70 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FRP 208 | Length 8 mm | In distribution |
| FLP 322 | Length 22 mm | In distribution |
| FRP 238 | Length 38 mm | In distribution |
| FHF 130 | Length 30 mm | In distribution |
| FRP 260 | Length 60 mm | In distribution |
| FHF 126 | Length 26 mm | In distribution |
| FRP 324 | Length 24 mm | In distribution |
| FRP 130 | Length 30 mm | In distribution |
| FHF 020 | Length 20 mm | In distribution |
| FRP 216 | Length 16 mm | In distribution |
| FHF 213 | Length 13 mm | In distribution |
| FHF 008 | Length 8 mm | In distribution |
| FLP 312 | Length 12 mm | In distribution |
| FRP 345 | Length 45 mm | In distribution |
| FHF 006 | Length 6 mm | In distribution |
| FRP 224 | Length 24 mm | In distribution |
| FLP 318 | Length 18 mm | In distribution |
| FHF 209 | Length 9 mm | In distribution |
| FLP 324 | Length 24 mm | In distribution |
| FRP 212 | Length 12 mm | In distribution |
| FLP 320 | Length 20 mm | In distribution |
| FHF 128 | Length 28 mm | In distribution |
| FHF 215 | Length 15 mm | In distribution |
| FHF 015 | Length 15 mm | In distribution |
| FHF 110 | Length 10 mm | In distribution |
| FLP 332 | Length 32 mm | In distribution |
| FLP 370 | Length 70 mm | In distribution |
| FRP 124 | Length 24 mm | In distribution |
| FHF 013 | Length 13 mm | In distribution |
| FHF 120 | Length 20 mm | In distribution |
| FHF 024 | Length 24 mm | In distribution |
| FHF 022 | Length 22 mm | In distribution |
| FRP 326 | Length 26 mm | In distribution |
| FRP 234 | Length 34 mm | In distribution |
| FLP 338 | Length 38 mm | In distribution |
| FRP 145 | Length 45 mm | In distribution |
| FRP 338 | Length 38 mm | In distribution |
| FRP 310 | Length 10 mm | In distribution |
| FRP 126 | Length 26 mm | In distribution |
| FHF 220 | Length 20 mm | In distribution |
| FHF 016 | Length 16 mm | In distribution |
| FRP 218 | Length 18 mm | In distribution |
| FRP 318 | Length 18 mm | In distribution |
| FHF 208 | Length 8 mm | In distribution |
| FRP 236 | Length 36 mm | In distribution |
| FHF 212 | Outer Diameter 1.5 mm | In distribution |
| FLP 316 | Length 16 mm | In distribution |
| FLP 345 | Length 45 mm | In distribution |
| FHF 028 | Length 28 mm | In distribution |
| FLP 326 | Length 26 mm | In distribution |
| FLP314 | Length 14 mm | In distribution |
| FRP 210 | Length 10 mm | In distribution |
| FRP 332 | Length 32 mm | In distribution |
| FLP 340 | Length 40 mm | In distribution |
| FRP 255 | Length 55 mm | In distribution |
| FRP 114 | Length 14 mm | In distribution |
| FRP 226 | Length 26 mm | In distribution |
| FHF 218 | Length 18 mm | In distribution |
| FHF 030 | Length 30 mm | In distribution |
| FRP 320 | Length 20 mm | In distribution |
| FRP 132 | Length 32 mm | In distribution |
| FRP 128 | Length 28 mm | In distribution |
| FRP 334 | Length 34 mm | In distribution |
| FRP 316 | Length 16 mm | In distribution |
| FRP 360 | Length 60 mm | In distribution |
| FRP 240 | Length 40 mm | In distribution |
| FRP 328 | Length 28 mm | In distribution |
| FRP 250 | Length 50 mm | In distribution |
| FRP 350 | Length 50 mm | In distribution |
| FLP 360 | Length 60 mm | In distribution |
| FRP 116 | Length 16 mm | In distribution |
| FHF 122 | Length 22 mm | In distribution |
| FLP 328 | Length 28 mm | In distribution |
| FHF 210 | Length 10 mm | In distribution |
| FHF 014 | Length 14 mm | In distribution |
| FRP 330 | Length 30 mm | In distribution |
| FRP 214 | Length 2.7 mm | In distribution |
| FHF 214 | Outer Diameter 1.5 mm | In distribution |
| FRP 122 | Length 22 mm | In distribution |
| FHF 211 | Length 11 mm | In distribution |
| FHF 011 | Length 14 mm | In distribution |
| FRP 245 | Length 45 mm | In distribution |
| FHF 116 | Length 16 mm | In distribution |
| FRP 140 | Length 40 mm | In distribution |
| FRP 160 | Length 60 mm | In distribution |
| FRP 322 | Length 22 mm | In distribution |
| FLP 365 | Length 65 mm | In distribution |
| FRP 340 | Length 40 mm | In distribution |
| FRP 308 | Length 8 mm | In distribution |
| FHF 114 | Length 14 mm | In distribution |
| FRP 312 | Length 12 mm | In distribution |
| FRP 112 | Length 12 mm | In distribution |
| FHF 012 | Length 12 mm | In distribution |
| FRP 228 | Length 28 mm | In distribution |
| FLP 336 | Length 36 mm | In distribution |
| FHF 018 | Length 18 mm | In distribution |
| FHF 106 | Length 6 mm | In distribution |
| FHF 108 | Length 8 mm | In distribution |
| FHF 007 | Length 7 mm | In distribution |
| FHF 216 | Length 16 mm | In distribution |
| FLP 334 | Length 34 mm | In distribution |
| FHF 206 | In distribution | |
| FHF 010 | Length 10 mm | In distribution |
| FHF 124 | Length 24 mm | In distribution |
| FLP 310 | Length 10 mm | In distribution |
| FHF 026 | Length 26 mm | In distribution |
| FHF 207 | Length 7 mm | In distribution |
| FRP 336 | Length 36 mm | In distribution |
| FLP 355 | Length 55 mm | In distribution |
| FLP 350 | Length 50 mm | In distribution |
| FRP 232 | Length 32 mm | In distribution |
| FRP 355 | Length 55 mm | In distribution |
| FRP 155 | Length 55 mm | In distribution |
| FLP 308 | Length 8 mm | In distribution |
| FHF 112 | Length 12 mm | In distribution |
| FRP 150 | Length 50 mm | In distribution |
| FRP 138 | Length 38 mm | In distribution |
| FHF 009 | Length 9 mm | In distribution |
| FLP 330 | Length 30 mm | In distribution |
| FHF 118 | Length 18 mm | In distribution |
| FRP 118 | Length 18 mm | In distribution |
| FRP 222 | Length 22 mm | In distribution |
| FRP 134 | Length 34 mm | In distribution |
| FRP 136 | Length 36 mm | In distribution |
| FRP 314 | Length 14 mm | In distribution |
| FRP 120 | Length 20 mm | In distribution |
| FRP 230 | Length 30 mm | In distribution |
| FRP 220 | Length 20 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.