GAP Endo-EXO Medullary System
GAP GUIDE WIRE SLEEVE FOR 1.6mm GUIDE WIRE
53manufacturers in China registered for this device type
42catalogue numbers in this listing
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 | Orthopediatrics Canada ULC, Canada |
|---|---|
| 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 | 2020-08-12 |
| Record revised | 2025-05-13 (version 7) |
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 |
| Storage | Special storage condition: keep at room temperature |
| Sizes | Length 150 to 457.2 mm; outer diameter 1.6 to 2.75 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GAP-SLS155 | In distribution | ||
| GAP-SCS200 | In distribution | ||
| GAP-KNB200 | In distribution | ||
| GAP-KDG360-PKG2 | Length 360 mm | 2 | In distribution |
| GAP-LSA150 | In distribution | ||
| GAP-SCS100 | In distribution | ||
| GAP-SGW116 | In distribution | ||
| GAP-TPR200 | In distribution | ||
| GAP-KWG020-PKG6 | Length 457.2 mm | 6 | In distribution |
| GAP-TGD200 | In distribution | ||
| GAP-SMS200 | In distribution | ||
| GAP-KNB100 | In distribution | ||
| GAP-CMP100 | In distribution | ||
| GAP-SDG120 | In distribution | ||
| GAP-SGW120 | In distribution | ||
| GAP-THA100 | In distribution | ||
| GAP-INE110 | In distribution | ||
| GAP-STH100 | In distribution | ||
| GAP-KDG360-PKG6 | Outer Diameter 2 mm | 6 | In distribution |
| GAP-IME200 | Length 150 mm | In distribution | |
| GAP-KWG020 | Outer Diameter 2 mm | In distribution | |
| GAP-KWG016-PKG6 | Length 457.2 mm | 6 | In distribution |
| GAP-APA100 | In distribution | ||
| GAP-KWG016 | Length 457.2 mm | In distribution | |
| GAP-SLS200 | In distribution | ||
| GAP-ILE120 | In distribution | ||
| GAP-IME100 | In distribution | ||
| GAP-MSP200 | In distribution | ||
| GAP-TGD100 | In distribution | ||
| GAP-MPW200 | In distribution | ||
| GAP-LCK080 | In distribution | ||
| GAP-DSA150 | In distribution | ||
| GAP-MSP100 | In distribution | ||
| GAP-TP116 | In distribution | ||
| GAP-LGO100 | In distribution | ||
| GAP-SDG200 | In distribution | ||
| GAP-SMS100 | In distribution | ||
| GAP-IME250 | Outer Diameter 2.35 mm | In distribution | |
| GAP-KWG020-PKG2 | Length 457.2 mm | 2 | In distribution |
| GAP-KWG016-PKG2 | Length 457.2 mm | 2 | In distribution |
| GAP-KDG360 | Outer Diameter 2 mm | In distribution | |
| GAP-INE200 | Length 150 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
2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-07-04 | Class II | Process control | During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX. | 6 units | |
| 2020-04-03 | Class III | Nonconforming Material/Component | The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label. | 3 units | 2020-11-20 |
| 2019-10-02 | Class II | Device Design | There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out. | 31 devices | 2020-10-26 |
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.