Optilock Upper Extremity Plating
50 catalogue numbers from 37722, 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
50catalogue 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) | K062494 |
| 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 |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 37722 | 3.5MM Ø 22MM LENGTH | In distribution |
| 37718 | 3.5MM Ø 18MM LENGTH | In distribution |
| 37756 | 3.5MM Ø 56MM LENGTH | In distribution |
| 36722 | 3.5MM Ø 22MM LENGTH | In distribution |
| 37726 | 3.5MM Ø 26MM LENGTH | In distribution |
| 37738 | 3.5MM Ø 38MM LENGTH | In distribution |
| 37102 | 2 HOLE | In distribution |
| 36756 | 3.5MM Ø 56MM LENGTH | In distribution |
| 36710 | 3.5MM Ø 10MM LENGTH | In distribution |
| 37732 | 3.5MM Ø 32MM LENGTH | In distribution |
| 37716 | 3.5MM Ø 16MM LENGTH | In distribution |
| 36736 | 3.5MM Ø 36MM LENGTH | In distribution |
| 36718 | 3.5MM Ø 18MM LENGTH | In distribution |
| 36726 | 3.5MM Ø 26MM LENGTH | In distribution |
| 36106 | 6 HOLE | In distribution |
| 36104 | 4 HOLE | In distribution |
| 37710 | 3.5MM Ø 10MM LENGTH | In distribution |
| 36730 | 3.5MM Ø 30MM LENGTH | In distribution |
| 36738 | 3.5MM Ø 38MM LENGTH | In distribution |
| 37760 | 3.5MM Ø 60MM LENGTH | In distribution |
| 36110 | 10 HOLE | In distribution |
| 37104 | 4 HOLE | In distribution |
| 37730 | 3.5MM Ø 30MM LENGTH | In distribution |
| 36728 | 3.5MM Ø 28MM LENGTH | In distribution |
| 36740 | 3.5MM Ø 40MM LENGTH | In distribution |
| 36102 | 2 HOLE | In distribution |
| 36724 | 3.5MM Ø 24MM LENGTH | In distribution |
| 37714 | 3.5MM Ø 14MM LENGTH | In distribution |
| 37748 | 3.5MM Ø 48MM LENGTH | In distribution |
| 36744 | 3.5MM Ø 44MM LENGTH | In distribution |
| 37734 | 3.5MM Ø 34MM LENGTH | In distribution |
| 36720 | 3.5MM Ø 20MM LENGTH | In distribution |
| 37752 | 3.5MM Ø 52MM LENGTH | In distribution |
| 36732 | 3.5MM Ø 32MM LENGTH | In distribution |
| 37724 | 3.5MM Ø 24MM LENGTH | In distribution |
| 36760 | 3.5MM Ø 60MM LENGTH | In distribution |
| 36714 | 3.5MM Ø 14MM LENGTH | In distribution |
| 36712 | 3.5MM Ø 12MM LENGTH | In distribution |
| 37728 | 3.5MM Ø 28MM LENGTH | In distribution |
| 37720 | 3.5MM Ø 20MM LENGTH | In distribution |
| 36734 | 3.5MM Ø 34MM LENGTH | In distribution |
| 36752 | 3.5MM Ø 52MM LENGTH | In distribution |
| 37744 | 3.5MM Ø 44MM LENGTH | In distribution |
| 37712 | 3.5MM Ø 12MM LENGTH | In distribution |
| 37736 | 3.5MM Ø 36MM LENGTH | In distribution |
| 36748 | 3.5MM Ø 48MM LENGTH | In distribution |
| 36716 | 3.5MM Ø 16MM LENGTH | In distribution |
| 37740 | 3.5MM Ø 40MM LENGTH | In distribution |
| 36742 | 3.5MM Ø 42MM LENGTH | In distribution |
| 37742 | 3.5MM Ø 42MM 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 |
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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2012-03-15 | Not classified | Labeling mix-ups | Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm. | 45 | 2013-08-29 |
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.