Cayman® Plate System
Torque Limiting Handle Size 35 in-lbs (4.0 N-m)
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2021-04-07 |
| Record revised | 2026-04-20 (version 5) |
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 |
| Sizes | Length 12 to 65 mm; outer diameter 2.5 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1208-90036 | In distribution | |
| 1208-90007 | In distribution | |
| 1208-90035 | In distribution | |
| SP-4103 | Hexalobe Size 25 | In distribution |
| 1208-90017 | In distribution | |
| SP-1344-02 | In distribution | |
| SP-1344-01 | In distribution | |
| 1208-90041 | In distribution | |
| 4508-90162 | Length 20 mm | In distribution |
| 1208-90029 | In distribution | |
| 1208-90016 | In distribution | |
| 1208-90010 | In distribution | |
| 4508-90161 | Length 20 mm | In distribution |
| 1208-90056 | In distribution | |
| 4508-90154 | Outer Diameter 2.5 mm | In distribution |
| 1208-90014 | In distribution | |
| 1408-90002 | In distribution | |
| PRO-1239 | In distribution | |
| 1208-90034 | In distribution | |
| PRO-1236 | In distribution | |
| 1208-90033 | Length 30 mm | In distribution |
| PRO-1197-01 | Length 30 mm | In distribution |
| 1208-90058 | In distribution | |
| 1208-90002 | Outer Diameter 3.5 mm | In distribution |
| 4508-90164 | Size 20 Hexalobe | In distribution |
| 4508-90159 | In distribution | |
| 1208-90012 | In distribution | |
| PRO-1197-03 | Outer Diameter 5.5 mm | In distribution |
| 1208-90037 | Length 20 mm | In distribution |
| 1208-90004 | In distribution | |
| 1208-90039 | Outer Diameter 6 mm | In distribution |
| 1208-90038 | Length 20 mm | In distribution |
| 1408-90003 | In distribution | |
| 4508-90160 | Length 12 mm | In distribution |
| 1208-90001 | Outer Diameter 4.5 mm | In distribution |
| 1208-90000 | Length 20 mm | In distribution |
| 1208-90003 | Length 65 mm | In distribution |
| PRO-1197-02 | Outer Diameter 4.5 mm | In distribution |
| 1208-90057 | In distribution | |
| 1208-90032 | Length 30 mm | In distribution |
| PRO-1197-04 | Length 60 mm | In distribution |
| 4508-90153 | In distribution | |
| 1408-90006 | In distribution | |
| 1208-90005 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
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.