ROI-T
43 catalogue numbers from IR9095R, listed by Ldr Spine USA, United States, under Orthopedic Manual Surgical Instrument. 53 manufacturers in China are registered for this product code.
53manufacturers in China registered for this device type
43catalogue numbers in this listing
1recall
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 | Ldr Spine USA, United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2018-12-13 |
| Record revised | 2025-01-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Height 7 to 16 mm; width 14 mm; length 100 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IR9095R | In distribution | |
| IR9038R | Width 14 mm | In distribution |
| IR9090R | In distribution | |
| IR9068R | Height 15 mm | In distribution |
| IR9039R | In distribution | |
| IR9028R | Height 15 mm | In distribution |
| IR9040R | Height 7 mm | In distribution |
| IR9140R | In distribution | |
| IR9042R | Height 9 mm | In distribution |
| IR9008R | In distribution | |
| IR9024R | Height 11 mm | In distribution |
| IR9097R | In distribution | |
| IR9067R | Height 14 mm | In distribution |
| IR9064R | Height 11 mm | In distribution |
| IR9027R | Height 14 mm | In distribution |
| IR9044R | Height 11 mm | In distribution |
| IR9065R | Height 12 mm | In distribution |
| IR9043R | Height 10 mm | In distribution |
| IR9060R | Height 7 mm | In distribution |
| IR9144R | In distribution | |
| IR9083R | In distribution | |
| IR9041R | Height 8 mm | In distribution |
| IR9138R | In distribution | |
| IR9066R | Height 13 mm | In distribution |
| IR9089R | In distribution | |
| IR9022R | Height 9 mm | In distribution |
| IR9145R | In distribution | |
| IR9026R | Height 13 mm | In distribution |
| IR9025R | Height 12 mm | In distribution |
| IR9139R | In distribution | |
| IR9096R | In distribution | |
| IR9069R | Height 15 mm | In distribution |
| IR9045R | Height 12 mm | In distribution |
| IR9091R | In distribution | |
| IR9063R | Height 10 mm | In distribution |
| IR9062R | Height 9 mm | In distribution |
| IR9061R | Height 8 mm | In distribution |
| IR9141R | In distribution | |
| IR9023R | Height 10 mm | In distribution |
| IR9081R | Length 100 mm | In distribution |
| IR9093R | In distribution | |
| IR9098R | In distribution | |
| IR9029R | Height 16 mm | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-08-29 | Class II | Device Design | The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury | 24 units | 2017-01-13 |
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.