Ozark Cervical Plate System
Ratcheting Torque Handle, Size 1.4 N-m
53manufacturers in China registered for this device type
151catalogue numbers in this listing
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 | 2020-10-21 |
| Record revised | 2026-04-20 (version 5) |
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 |
| Sizes | Length 10 to 110 mm; outer diameter 2.3 to 2.5 mm |
| Distribution end date | 2024-05-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP-4065-86 | Length 108 mm | In distribution |
| SP-4065-61 | Length 90 mm | In distribution |
| SP-4174-01 | Outer Diameter 2.5 mm | In distribution |
| SP-4065-04 | Length 51 mm | In distribution |
| 8801-90064 | In distribution | |
| SP-4002-01 | In distribution | |
| SP-4065-28 | 3 Level | In distribution |
| SP-4027-03 | Length 24 mm | In distribution |
| SP-4065-14 | 3 Level | In distribution |
| SP-4065-72 | 4 Level | In distribution |
| SP-4065-12 | 3 Level | In distribution |
| SP-4065-13 | 3 Level | In distribution |
| SP-4065-24 | 3 Level | In distribution |
| 8801-90075 | In distribution | |
| SP-4065-38 | 4 Level | In distribution |
| SP-4065-15 | 3 Level | In distribution |
| SP-4065-78 | 5 Level | In distribution |
| SP-4065-79 | 5 Level | In distribution |
| SP-4002-04 | In distribution | |
| SP-4195-02 | In distribution | |
| SP-4065-69 | 4 Level | In distribution |
| SP-4195-01 | In distribution | |
| SP-4065-10 | 3 Level | In distribution |
| 8801-90077 | In distribution | |
| SP-4120 | Outer Diameter 2.3 mm | In distribution |
| SP-4065-81 | Length 103 mm | In distribution |
| PRO-1427-10 | Outer Diameter 2.3 mm | In distribution |
| SP-3114-01 | In distribution | |
| SP-4027-04 | Length 22 mm | In distribution |
| SP-4065-49 | Length 78 mm | In distribution |
| SP-3114-02 | In distribution | |
| PRO-1156 | In distribution | |
| SP-4065-80 | Length 102 mm | In distribution |
| SP-4027-02 | Length 22 mm | In distribution |
| SP-4065-40 | Length 69 mm | In distribution |
| SP-4065-20 | 3 Level | In distribution |
| SP-4065-56 | Length 85 mm | In distribution |
| 8801-90084 | In distribution | |
| PRO-1427-12 | Length 12 mm | In distribution |
| SP-4065-67 | Length 96 mm | In distribution |
| PRO-1051 | In distribution | |
| PRO-1149 | In distribution | |
| SP-4065-53 | Length 82 mm | In distribution |
| 8801-90044 | Length 10 mm | In distribution |
| SP-4065-60 | 4 Level | In distribution |
| SP-4065-21 | Length 68 mm | In distribution |
| SP-4065-30 | 3 Level | In distribution |
| SP-4065-59 | Length 88 mm | In distribution |
| SP-4065-51 | 4 Level | In distribution |
| SP-4027-01 | Length 20 mm | In distribution |
| SP-4065-18 | Length 65 mm | In distribution |
| SP-4065-34 | Length 63 mm | In distribution |
| SP-4065-87 | Length 109 mm | In distribution |
| SP-4047-02 | In distribution | |
| SP-4174-03 | Length 14 mm | In distribution |
| SP-4065-16 | 3 Level | In distribution |
| SP-4065-02 | Length 49 mm | In distribution |
| SP-4065-54 | 4 Level | In distribution |
| SP-4065-41 | 4 Level | In distribution |
| 8801-90054 | Outer Diameter 2.3 mm | In distribution |
| SP-4065-03 | 3 Level | In distribution |
| PRO-1372-02 | In distribution | |
| SP-4065-68 | Length 97 mm | In distribution |
| PRO-1243-01 | In distribution | |
| SP-4065-36 | Length 65 mm | In distribution |
| SP-4065-27 | Length 74 mm | In distribution |
| SP-4065-35 | Length 64 mm | In distribution |
| SP-4065-64 | Length 93 mm | In distribution |
| 8801-90031 | In distribution | |
| SP-4065-31 | Length 78 mm | In distribution |
| SP-4065-23 | 3 Level | In distribution |
| SP-4065-44 | 4 Level | In distribution |
| SP-4065-42 | Length 71 mm | In distribution |
| SP-4065-76 | Length 98 mm | In distribution |
| SP-4065-39 | 4 Level | In distribution |
| 8801-90056 | Outer Diameter 2.3 mm | In distribution |
| SP-4065-74 | 5 Level | In distribution |
| 8801-90067 | Outer Diameter 2.3 mm | In distribution |
| SP-4047-01 | In distribution | |
| SP-4065-85 | Length 107 mm | In distribution |
| SP-4065-83 | 5 Level | In distribution |
| SP-4065-25 | 3 Level | In distribution |
| PRO-1061 | In distribution | |
| SP-4065-43 | Length 72 mm | In distribution |
| SP-4065-58 | 4 Level | In distribution |
| SP-4002-03 | In distribution | |
| SP-4065-08 | 3 Level | In distribution |
| SP-4065-63 | 4 Level | In distribution |
| SP-4065-70 | 4 Level | In distribution |
| SP-4065-29 | 3 Level | In distribution |
| 8801-90063 | In distribution | |
| SP-3114-03 | In distribution | |
| PRO-1427-14 | Length 14 mm | In distribution |
| 8801-90076 | In distribution | |
| SP-4065-88 | 5 Level | In distribution |
| PRO-1427-16 | Length 16 mm | In distribution |
| SP-4174-04 | Outer Diameter 2.5 mm | In distribution |
| SP-4212 | Size 10 Hexalobe | In distribution |
| 8801-90074 | In distribution | |
| SP-4065-52 | Length 81 mm | In distribution |
| 2601-90008 | In distribution | |
| SP-4065-77 | Length 99 mm | In distribution |
| SP-4065-62 | 4 Level | In distribution |
| SP-4065-17 | Length 64 mm | In distribution |
| 8801-90034 | In distribution | |
| SP-4065-73 | Length 95 mm | In distribution |
| 8801-90002 | In distribution | |
| SP-4065-65 | Length 94 mm | In distribution |
| SP-4065-26 | 3 Level | In distribution |
| SP-4065-22 | 3 Level | In distribution |
| 8801-90078 | In distribution | |
| SP-4065-33 | Length 62 mm | In distribution |
| SP-4065-07 | Length 54 mm | In distribution |
| PRO-1427-18 | Length 18 mm | In distribution |
| SP-4065-46 | Length 75 mm | In distribution |
| 8801-90033 | In distribution | |
| SP-4065-45 | 4 Level | In distribution |
| PRO-1425 | In distribution | |
| SP-4065-06 | Length 53 mm | In distribution |
| 8801-90007 | In distribution | |
| 8801-90073 | Length 18 mm | In distribution |
| SP-4065-84 | Length 106 mm | In distribution |
| PRO-1243-02 | In distribution | |
| SP-4174-02 | Outer Diameter 2.5 mm | In distribution |
| SP-4065-47 | 4 Level | In distribution |
| SP-4065-37 | Length 66 mm | In distribution |
| SP-4093 | Size 10 Hexalobe | In distribution |
| SP-4065-05 | 3 Level | In distribution |
| SP-4065-66 | Length 95 mm | In distribution |
| SP-4177 | 1.4 N-m Torque Limit | In distribution |
| 8801-90071 | Length 16 mm | In distribution |
| 8801-90069 | Outer Diameter 2.3 mm | In distribution |
| SP-4065-01 | 3 Level | In distribution |
| SP-4065-57 | 4 Level | In distribution |
| SP-4065-32 | 4 Level | In distribution |
| SP-4065-48 | Length 77 mm | In distribution |
| SP-4119-02 | In distribution | |
| SP-4065-75 | Length 97 mm | In distribution |
| SP-4119-01 | In distribution | |
| SP-4002-02 | In distribution | |
| SP-4065-19 | Length 66 mm | In distribution |
| PRO-1372-01 | In distribution | |
| SP-4065-82 | 5 Level | In distribution |
| SP-4065-55 | Length 84 mm | In distribution |
| 8801-90065 | Outer Diameter 2.3 mm | In distribution |
| SP-4065-09 | 3 Level | In distribution |
| SP-4065-11 | Length 58 mm | In distribution |
| 8801-90006 | In distribution | |
| SP-4065-50 | Length 79 mm | In distribution |
| SP-4065-71 | 4 Level | In distribution |
| SP-4014 | Withdrawn |
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.