Variable Angle Compression Screw
75 catalogue numbers from FCS 532, 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
75catalogue 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 | 2015-09-16 |
| 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 |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 6 to 60 mm; outer diameter 2.4 to 4 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FCS 532 | Length 32 mm | In distribution |
| FCS 314 | Length 14 mm | In distribution |
| FCS 560 | Length 60 mm | In distribution |
| FCS 555 | Length 55 mm | In distribution |
| FCS 316 | Length 16 mm | In distribution |
| FCS 618 | Length 18 mm | In distribution |
| FCS 222 | Length 22 mm | In distribution |
| FCS 622 | Length 22 mm | In distribution |
| FCS 214 | Length 14 mm | In distribution |
| FCS 630 | Length 30 mm | In distribution |
| FCS 210 | Length 10 mm | In distribution |
| FCS 640 | Length 40 mm | In distribution |
| FCS 430 | Length 30 mm | In distribution |
| FCS 416 | Length 16 mm | In distribution |
| FCS 534 | Length 34 mm | In distribution |
| FCS 550 | Length 50 mm | In distribution |
| FCS 650 | Length 50 mm | In distribution |
| FCS 528 | Length 28 mm | In distribution |
| FCS 512 | Length 12 mm | In distribution |
| FCS 226 | Length 26 mm | In distribution |
| FCS 308 | Length 8 mm | In distribution |
| FCS 406 | Length 6 mm | In distribution |
| FCS 516 | Length 16 mm | In distribution |
| FCS 414 | Length 14 mm | In distribution |
| FCS 216 | Length 16 mm | In distribution |
| FCS 418 | Length 18 mm | In distribution |
| FCS 620 | Length 20 mm | In distribution |
| FCS 518 | Length 18 mm | In distribution |
| FCS 614 | Length 14 mm | In distribution |
| FCS 616 | Length 16 mm | In distribution |
| FCS 408 | Length 8 mm | In distribution |
| FCS 634 | Length 34 mm | In distribution |
| FCS 636 | Length 36 mm | In distribution |
| FCS 645 | Length 45 mm | In distribution |
| FCS 612 | Length 12 mm | In distribution |
| FCS 624 | Length 24 mm | In distribution |
| FCS 312 | Length 12 mm | In distribution |
| FCS 220 | Length 20 mm | In distribution |
| FCS 514 | Length 14 mm | In distribution |
| FCS 328 | Length 28 mm | In distribution |
| FCS 610 | Length 10 mm | In distribution |
| FCS 522 | Length 22 mm | In distribution |
| FCS 660 | Length 60 mm | In distribution |
| FCS 508 | Length 8 mm | In distribution |
| FCS 545 | Length 45 mm | In distribution |
| FCS 540 | Length 40 mm | In distribution |
| FCS 424 | Outer Diameter 2.4 mm | In distribution |
| FCS 632 | Length 32 mm | In distribution |
| FCS 530 | Length 30 mm | In distribution |
| FCS 538 | Length 38 mm | In distribution |
| FCS 428 | Outer Diameter 2.4 mm | In distribution |
| FCS 324 | Length 24 mm | In distribution |
| FCS 218 | Length 18 mm | In distribution |
| FCS 638 | Length 38 mm | In distribution |
| FCS 524 | Length 24 mm | In distribution |
| FCS 412 | Length 12 mm | In distribution |
| FCS 212 | Length 12 mm | In distribution |
| FCS 422 | Length 22 mm | In distribution |
| FCS 224 | Length 24 mm | In distribution |
| FCS 318 | Length 18 mm | In distribution |
| FCS 426 | Length 26 mm | In distribution |
| FCS 536 | Length 36 mm | In distribution |
| FCS 326 | Length 26 mm | In distribution |
| FCS 510 | Length 10 mm | In distribution |
| FCS 526 | Length 26 mm | In distribution |
| FCS 310 | Length 10 mm | In distribution |
| FCS 320 | Length 20 mm | In distribution |
| FCS 420 | Length 20 mm | In distribution |
| FCS 410 | Length 10 mm | In distribution |
| FCS 628 | Outer Diameter 4 mm | In distribution |
| FCS 655 | Length 55 mm | In distribution |
| FCS 626 | Length 26 mm | In distribution |
| FCS 520 | Length 20 mm | In distribution |
| FCS 330 | Length 30 mm | In distribution |
| FCS 322 | Length 22 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.