LITe Decompression
Specialty LITe Decompression Initial Dilator No Cannulation
53manufacturers in China registered for this device type
68catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-11-20 |
| Record revised | 2022-09-16 (version 5) |
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, manufacturing date |
| Sizes | Length 3 to 12 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48081612 | Length 12.0 cm | In distribution |
| 48081604 | Diameter: 16.0 Millimeter | In distribution |
| 48080230 | In distribution | |
| 48081803 | Diameter: 18.0 Millimeter | In distribution |
| 48081204 | Length 4.0 cm | In distribution |
| 48081409 | Diameter: 14.0 Millimeter | In distribution |
| 48082210 | Length 10.5 cm | In distribution |
| IS4506REL | Diameter: 22.0 Millimeter | In distribution |
| 48082604 | Length 4.0 cm | In distribution |
| 48081807 | Length 7.0 cm | In distribution |
| 48082610 | Length 10.5 cm | In distribution |
| 48082204 | Diameter: 22.0 Millimeter | In distribution |
| 48080016 | In distribution | |
| 48082603 | Length 3.0 cm | In distribution |
| 48082607 | Diameter: 26.0 Millimeter | In distribution |
| 48081610 | Length 10.5 cm | In distribution |
| 48081403 | Diameter: 14.0 Millimeter | In distribution |
| 48081608 | Length 8.0 cm | In distribution |
| 48081404 | Length 4.0 cm | In distribution |
| 48080006 | In distribution | |
| 48081207 | Diameter: 12.0 Millimeter | In distribution |
| 48080002BB | Diameter: 26.0 Millimeter | In distribution |
| 48081804 | Length 4.0 cm | In distribution |
| 48080020 | In distribution | |
| 48081206 | Length 6.0 cm | In distribution |
| 48080000 | In distribution | |
| 48080002CC | In distribution | |
| 48081805 | Diameter: 18.0 Millimeter | In distribution |
| 48081205 | Length 5.0 cm | In distribution |
| 48081208 | Length 8.0 cm | In distribution |
| 48080014 | In distribution | |
| 48082605 | Diameter: 26.0 Millimeter | In distribution |
| 48081405 | Diameter: 14.0 Millimeter | In distribution |
| 48082206 | Length 6.0 cm | In distribution |
| 48081406 | Diameter: 14.0 Millimeter | In distribution |
| 48081408 | Length 8.0 cm | In distribution |
| 48082608 | Diameter: 26.0 Millimeter | In distribution |
| 48081808 | Diameter: 18.0 Millimeter | In distribution |
| 48080022 | In distribution | |
| 48081809 | Diameter: 18.0 Millimeter | In distribution |
| 48082207 | Length 7.0 cm | In distribution |
| 48082209 | Diameter: 22.0 Millimeter | In distribution |
| 48080018 | In distribution | |
| 48082208 | Length 8.0 cm | In distribution |
| 48081606 | Length 6.0 cm | In distribution |
| 48081609 | Length 9.0 cm | In distribution |
| IS4421REL | Diameter: 20.0 Millimeter | In distribution |
| 48080002AA | Diameter: 16.0 Millimeter | In distribution |
| 48082203 | Diameter: 22.0 Millimeter | In distribution |
| IS4479REL | Diameter: 22.0 Millimeter | In distribution |
| 48082612 | Diameter: 26.0 Millimeter | In distribution |
| IS4524REL | In distribution | |
| 48082606 | Length 6.0 cm | In distribution |
| 48080002 | In distribution | |
| 48080012 | In distribution | |
| 48081203 | Diameter: 12.0 Millimeter | In distribution |
| 48082212 | Diameter: 22.0 Millimeter | In distribution |
| 48081407 | Length 7.0 cm | In distribution |
| IS4480REL | In distribution | |
| 48081605 | Length 5.0 cm | In distribution |
| 48081603 | Diameter: 16.0 Millimeter | In distribution |
| 48081209 | Length 9.0 cm | In distribution |
| 48080001 | In distribution | |
| 48082205 | Length 5.0 cm | In distribution |
| 48080026 | In distribution | |
| 48081607 | Diameter: 16.0 Millimeter | In distribution |
| 48082609 | Diameter: 26.0 Millimeter | In distribution |
| 48081806 | Length 6.0 cm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K941605 | 1994-08-05 |
| K843942 | 1985-04-15 |
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 |
|---|---|---|---|---|---|---|
| Stryker Spine | UDI-DI | 2023-11-01 | Class II | Nonconforming Material/Component | Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft. | 9 |
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 2025-03-28 | Class II | Device Design | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. | 1588 units | |
| 2025-03-28 | Class II | Device Design | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. | 6407 units | |
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 320 | 2019-04-16 |
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.