Smple Submuscular Plating System
97 catalogue numbers from 14-448438, listed by Biomet Orthopedics, United States, under Screw, Fixation, Bone. 31 manufacturers in China are registered for this product code.
31manufacturers in China registered for this device type
97catalogue numbers in this listing
4510(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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K093983 |
| Record published | 2015-10-24 |
| Record revised | 2025-11-20 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-448438 | 4.5MM Ø 38MM LENGTH | In distribution |
| 14-448424 | 4.5MM Ø 24MM LENGTH | In distribution |
| 14-448418 | 4.5MM Ø 18MM LENGTH | In distribution |
| 14-448435 | 4.5MM Ø 35MM LENGTH | In distribution |
| 14-448420 | 4.5MM Ø 20MM LENGTH | In distribution |
| 14-448437 | 4.5MM Ø 37MM LENGTH | In distribution |
| 14-448658 | 5.5MM Ø 58MM LENGTH | In distribution |
| 14-448414 | 4.5MM Ø 14MM LENGTH | In distribution |
| 14-448333 | 4.5MM Ø 33MM LENGTH | In distribution |
| 14-448654 | 5.5MM Ø 54MM LENGTH | In distribution |
| 14-448478 | 4.5MM Ø 78MM LENGTH | In distribution |
| 14-448575 | 5.5MM Ø 75MM LENGTH | In distribution |
| 14-448310 | 4.5MM Ø 10MM LENGTH | In distribution |
| 14-448322 | 4.5MM Ø 22MM LENGTH | In distribution |
| 14-448456 | 4.5MM Ø 56MM LENGTH | In distribution |
| 14-448459 | 4.5MM Ø 59MM LENGTH | In distribution |
| 14-448355 | 4.5MM Ø 55MM LENGTH | In distribution |
| 14-448487 | 4.5MM Ø 87MM LENGTH | In distribution |
| 14-448016 | In distribution | |
| 14-448423 | 4.5MM Ø 23MM LENGTH | In distribution |
| 14-448323 | 4.5MM Ø 23MM LENGTH | In distribution |
| 14-448661 | 5.5MM Ø 61MM LENGTH | In distribution |
| 14-448345 | 4.5MM Ø 45MM LENGTH | In distribution |
| 14-448481 | 4.5MM Ø 81MM LENGTH | In distribution |
| 14-448465 | 4.5MM Ø 65MM LENGTH | In distribution |
| 14-448472 | 4.5MM Ø 72MM LENGTH | In distribution |
| 14-448672 | 5.5MM Ø 72MM LENGTH | In distribution |
| 14-448328 | 4.5MM Ø 28MM LENGTH | In distribution |
| 14-448655 | 5.5MM Ø 55MM LENGTH | In distribution |
| 14-448321 | 4.5MM Ø 21MM LENGTH | In distribution |
| 14-448475 | 4.5MM Ø 75MM LENGTH | In distribution |
| 14-448494 | 4.5MM Ø 94MM LENGTH | In distribution |
| 14-448657 | 5.5MM Ø 57MM LENGTH | In distribution |
| 14-448666 | 5.5MM Ø 66MM LENGTH | In distribution |
| 14-448489 | 4.5MM Ø 89MM LENGTH | In distribution |
| 14-448110 | In distribution | |
| 14-448565 | 5.5MM Ø 65MM LENGTH | In distribution |
| 14-448668 | 5.5MM Ø 68MM LENGTH | In distribution |
| 14-448014 | In distribution | |
| 14-448335 | 4.5MM Ø 35MM LENGTH | In distribution |
| 14-448448 | 4.5MM Ø 48MM LENGTH | In distribution |
| 14-448550 | 5.5MM Ø 50MM LENGTH | In distribution |
| 14-448112 | In distribution | |
| 14-448555 | 5.5MM Ø 55MM LENGTH | In distribution |
| 14-448334 | 4.5MM Ø 34MM LENGTH | In distribution |
| 14-448411 | 4.5MM Ø 11MM LENGTH | In distribution |
| 14-448570 | 5.5MM Ø 70MM LENGTH | In distribution |
| 14-448560 | 5.5MM Ø 60MM LENGTH | In distribution |
| 14-448214 | In distribution | |
| 14-448490 | 4.5MM Ø 90MM LENGTH | In distribution |
| 14-448443 | 4.5MM Ø 43MM LENGTH | In distribution |
| 14-448432 | 4.5MM Ø 32MM LENGTH | In distribution |
| 14-448320 | 4.5MM Ø 20MM LENGTH | In distribution |
| 14-448419 | 4.5MM Ø 19MM LENGTH | In distribution |
| 14-448010 | In distribution | |
| 14-448474 | 4.5MM Ø 74MM LENGTH | In distribution |
| 14-448331 | 4.5MM Ø 31MM LENGTH | In distribution |
| 14-448216 | In distribution | |
| 14-448018 | In distribution | |
| 14-448492 | 4.5MM Ø 92MM LENGTH | In distribution |
| 14-448480 | 4.5MM Ø 80MM LENGTH | In distribution |
| 14-448415 | 4.5MM Ø 15MM LENGTH | In distribution |
| 14-448457 | 4.5MM Ø 57MM LENGTH | In distribution |
| 14-448470 | 4.5MM Ø 70MM LENGTH | In distribution |
| 14-448467 | 4.5MM Ø 67MM LENGTH | In distribution |
| 14-448330 | 4.5MM Ø 30MM LENGTH | In distribution |
| 14-448469 | 4.5MM Ø 69MM LENGTH | In distribution |
| 14-448439 | 4.5MM Ø 39MM LENGTH | In distribution |
| 14-448218 | In distribution | |
| 14-448116 | In distribution | |
| 14-448473 | 4.5MM Ø 73MM LENGTH | In distribution |
| 14-448663 | 5.5MM Ø 63MM LENGTH | In distribution |
| 14-448441 | 4.5MM Ø 41MM LENGTH | In distribution |
| 14-448674 | 5.5MM Ø 74MM LENGTH | In distribution |
| 14-448495 | 4.5MM Ø 95MM LENGTH | In distribution |
| 14-448461 | 4.5MM Ø 61MM LENGTH | In distribution |
| 14-448462 | 4.5MM Ø 62MM LENGTH | In distribution |
| 14-448651 | 5.5MM Ø 51MM LENGTH | In distribution |
| 14-448667 | 5.5MM Ø 67MM LENGTH | In distribution |
| 14-448482 | 4.5MM Ø 82MM LENGTH | In distribution |
| 14-448652 | 5.5MM Ø 52MM LENGTH | In distribution |
| 14-448327 | 4.5MM Ø 27MM LENGTH | In distribution |
| 14-448670 | 5.5MM Ø 70MM LENGTH | In distribution |
| 14-448466 | 4.5MM Ø 66MM LENGTH | In distribution |
| 14-448360 | 4.5MM Ø 60MM LENGTH | In distribution |
| 14-448476 | 4.5MM Ø 76MM LENGTH | In distribution |
| 14-448454 | 4.5MM Ø 54MM LENGTH | In distribution |
| 14-448329 | 4.5MM Ø 29MM LENGTH | In distribution |
| 14-448336 | 4.5MM Ø 36MM LENGTH | In distribution |
| 14-448312 | 4.5MM Ø 12MM LENGTH | In distribution |
| 14-448332 | 4.5MM Ø 32MM LENGTH | In distribution |
| 14-448433 | 4.5MM Ø 33MM LENGTH | In distribution |
| 14-448464 | 4.5MM Ø 64MM LENGTH | In distribution |
| 14-448006 | In distribution | |
| 14-448427 | 4.5MM Ø 27MM LENGTH | In distribution |
| 14-448484 | 4.5MM Ø 84MM LENGTH | In distribution |
| 14-448451 | 4.5MM Ø 51MM 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 |
|---|---|
| K033355 | 2004-06-30 |
| K024086 | 2003-01-09 |
| K021254 | 2002-07-17 |
| K013534 | 2001-12-17 |
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.