OptiMesh Multiplanar Expandable Interbody Fusion System
Guide Pin, Trocar/Round, 2.4mm Dia. X 508mm Long
53manufacturers in China registered for this device type
66catalogue numbers in this listing
4recalls on this code
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 | Spineology Inc., United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-16 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Outer diameter 1.1 to 14.9 mm; needle gauge 8 to 11 G; length 15 to 20.3 cm; length 461 to 635 mm; lumen/inner diameter 4 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 35-06-37 | In distribution | |
| 35-01-31 | In distribution | |
| 92-01-01 | Outer Diameter 5.5 mm | In distribution |
| 32-15-185 | Outer Diameter 2.4 mm | In distribution |
| 10-01-68 | Needle Gauge 8 G | In distribution |
| 33-10-22 | In distribution | |
| 102-71-01 | In distribution | |
| 32-28-005 | In distribution | |
| 102-64-01-4 | In distribution | |
| 102-69-01 | In distribution | |
| 35-06-82 | In distribution | |
| 10-01-99 | Needle Gauge 8 G | In distribution |
| 10-01-100 | In distribution | |
| 102-79-01 | In distribution | |
| 10-01-87 | Needle Gauge 11 G | In distribution |
| 77-03-02 | In distribution | |
| 32-15-150-2 | Outer Diameter 2.4 mm | In distribution |
| 33-04-01 | In distribution | |
| 33-02-11 | In distribution | |
| 10-46-40 | In distribution | |
| 102-66-01 | In distribution | |
| 35-06-81 | In distribution | |
| 32-30-16 | In distribution | |
| 102-64-01-2 | In distribution | |
| 33-09-01 | In distribution | |
| 32-30-43 | In distribution | |
| 77-03-01 | In distribution | |
| 32-15-09 | In distribution | |
| 35-07-126 | In distribution | |
| 33-02-10 | In distribution | |
| 32-27-47 | In distribution | |
| 17-02-01 | Outer Diameter 1.4 mm | In distribution |
| 33-08-10 | In distribution | |
| 102-45-01 | Lumen/Inner Diameter 4 mm | In distribution |
| 33-08-11 | In distribution | |
| 35-06-72 | In distribution | |
| 33-08-04 | In distribution | |
| 102-64-04 | In distribution | |
| 10-01-86 | Needle Gauge 11 G | In distribution |
| 102-49-12 | In distribution | |
| 35-06-31 | In distribution | |
| 102-54-01 | Outer Diameter 5.5 mm | In distribution |
| 10-46-38 | In distribution | |
| 33-09-15 | In distribution | |
| 32-30-08-2 | In distribution | |
| 32-27-85 | Outer Diameter 4.5 mm | In distribution |
| 102-64-01-1 | In distribution | |
| 33-10-25 | In distribution | |
| 102-47-01 | Outer Diameter 4.75 mm | In distribution |
| 33-09-13 | In distribution | |
| 60-03-003 | In distribution | |
| 33-09-14 | In distribution | |
| 33-02-12 | In distribution | |
| 33-08-02 | In distribution | |
| 33-08-06 | In distribution | |
| 35-07-01 | In distribution | |
| 33-05-09 | In distribution | |
| 33-10-26 | In distribution | |
| 70-02-030 | Outer Diameter 1.1 mm | In distribution |
| 33-06-01 | In distribution | |
| 10-01-162 | Needle Gauge 8 G | In distribution |
| 102-64-01-3 | In distribution | |
| 33-08-12 | In distribution | |
| 33-08-03 | In distribution | |
| 35-06-38 | In distribution | |
| 35-07-130 | 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Spineology Inc. | UDI-DI | 2024-09-16 | Class II | Under Investigation by firm | Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique. | 190 units |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-01-28 | Not classified | Other | Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials. | 40 | 2005-11-17 |
| 2005-01-28 | Not classified | Other | Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials. | 3392 | 2005-11-17 |
| 2005-01-28 | Not classified | Other | Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials. | 870 | 2005-11-17 |
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.