Smple Submuscular Plating System
74 catalogue numbers from 14-448326, listed by Biomet Orthopedics, United States, under Plate, Fixation, Bone. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
74catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 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 |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-448326 | 4.5MM Ø 26MM LENGTH | In distribution |
| 14-448442 | 4.5MM Ø 42MM LENGTH | In distribution |
| 14-448318 | 4.5MM Ø 18MM LENGTH | In distribution |
| 14-448428 | 4.5MM Ø 28MM LENGTH | In distribution |
| 14-448314 | 4.5MM Ø 14MM LENGTH | In distribution |
| 14-448455 | 4.5MM Ø 55MM LENGTH | In distribution |
| 14-448491 | 4.5MM Ø 91MM LENGTH | In distribution |
| 14-448316 | 4.5MM Ø 16MM LENGTH | In distribution |
| 14-448425 | 4.5MM Ø 25MM LENGTH | In distribution |
| 14-448452 | 4.5MM Ø 52MM LENGTH | In distribution |
| 14-448664 | 5.5MM Ø 64MM LENGTH | In distribution |
| 14-448660 | 5.5MM Ø 60MM LENGTH | In distribution |
| 14-448485 | 4.5MM Ø 85MM LENGTH | In distribution |
| 14-448662 | 5.5MM Ø 62MM LENGTH | In distribution |
| 14-448450 | 4.5MM Ø 50MM LENGTH | In distribution |
| 14-448800 | In distribution | |
| 14-448315 | 4.5MM Ø 15MM LENGTH | In distribution |
| 14-448650 | 5.5MM Ø 50MM LENGTH | In distribution |
| 14-448671 | 5.5MM Ø 71MM LENGTH | In distribution |
| 14-448313 | 4.5MM Ø 13MM LENGTH | In distribution |
| 14-448656 | 5.5MM Ø 56MM LENGTH | In distribution |
| 14-448673 | 5.5MM Ø 73MM LENGTH | In distribution |
| 14-448447 | 4.5MM Ø 47MM LENGTH | In distribution |
| 14-448653 | 5.5MM Ø 53MM LENGTH | In distribution |
| 14-448471 | 4.5MM Ø 71MM LENGTH | In distribution |
| 14-448426 | 4.5MM Ø 26MM LENGTH | In distribution |
| 14-448434 | 4.5MM Ø 34MM LENGTH | In distribution |
| 14-448325 | 4.5MM Ø 25MM LENGTH | In distribution |
| 14-448114 | In distribution | |
| 14-448483 | 4.5MM Ø 83MM LENGTH | In distribution |
| 14-448449 | 4.5MM Ø 49MM LENGTH | In distribution |
| 14-448410 | 4.5MM Ø 10MM LENGTH | In distribution |
| 14-448444 | 4.5MM Ø 44MM LENGTH | In distribution |
| 14-448675 | 5.5MM Ø 75MM LENGTH | In distribution |
| 14-448659 | 5.5MM Ø 59MM LENGTH | In distribution |
| 14-448805S | In distribution | |
| 14-448365 | 4.5MM Ø 65MM LENGTH | In distribution |
| 14-448311 | 4.5MM Ø 11MM LENGTH | In distribution |
| 14-448445 | 4.5MM Ø 45MM LENGTH | In distribution |
| 14-448669 | 5.5MM Ø 69MM LENGTH | In distribution |
| 14-448486 | 4.5MM Ø 86MM LENGTH | In distribution |
| 14-448340 | 4.5MM Ø 40MM LENGTH | In distribution |
| 14-448477 | 4.5MM Ø 77MM LENGTH | In distribution |
| 14-448429 | 4.5MM Ø 29MM LENGTH | In distribution |
| 14-448436 | 4.5MM Ø 36MM LENGTH | In distribution |
| 14-448012 | In distribution | |
| 14-448463 | 4.5MM Ø 63MM LENGTH | In distribution |
| 14-448210 | In distribution | |
| 14-448488 | 4.5MM Ø 88MM LENGTH | In distribution |
| 14-448421 | 4.5MM Ø 21MM LENGTH | In distribution |
| 14-448008 | In distribution | |
| 14-448317 | 4.5MM Ø 17MM LENGTH | In distribution |
| 14-448479 | 4.5MM Ø 79MM LENGTH | In distribution |
| 14-448350 | 4.5MM Ø 50MM LENGTH | In distribution |
| 14-448208 | In distribution | |
| 14-448212 | In distribution | |
| 14-448431 | 4.5MM Ø 31MM LENGTH | In distribution |
| 14-448460 | 4.5MM Ø 60MM LENGTH | In distribution |
| 14-448800S | In distribution | |
| 14-448430 | 4.5MM Ø 30MM LENGTH | In distribution |
| 14-448416 | 4.5MM Ø 16MM LENGTH | In distribution |
| 14-448324 | 4.5MM Ø 24MM LENGTH | In distribution |
| 14-448422 | 4.5MM Ø 22MM LENGTH | In distribution |
| 14-448493 | 4.5MM Ø 93MM LENGTH | In distribution |
| 14-448319 | 4.5MM Ø 19MM LENGTH | In distribution |
| 14-448118 | In distribution | |
| 14-448417 | 4.5MM Ø 17MM LENGTH | In distribution |
| 14-448337 | 4.5MM Ø 37MM LENGTH | In distribution |
| 14-448440 | 4.5MM Ø 40MM LENGTH | In distribution |
| 14-448453 | 4.5MM Ø 53MM LENGTH | In distribution |
| 14-448665 | 5.5MM Ø 65MM LENGTH | In distribution |
| 14-448458 | 4.5MM Ø 58MM LENGTH | In distribution |
| 14-448468 | 4.5MM Ø 68MM LENGTH | In distribution |
| 14-448446 | 4.5MM Ø 46MM LENGTH | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243761 | 2025-02-19 |
| K022515 | 2002-09-17 |
| K020221 | 2002-04-02 |
| K013657 | 2001-12-03 |
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.