Keystone Alif System
Cup Curette Size 6 Racetrack Cup Up-angled Short handle
53manufacturers in China registered for this device type
78catalogue 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 | Evolution Spine, LLC, United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-11 |
| Record revised | 2024-05-30 (version 2) |
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 | Width 24 to 29 mm; depth 30 to 40 mm; angle 8 to 14 °; height 10 to 18 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EP-019 | In distribution | |
| EP-003 | In distribution | |
| A-2616 | Width 28 mm | In distribution |
| 830-1206-0M | In distribution | |
| EP-023 | In distribution | |
| EP-028 | In distribution | |
| EP-021 | In distribution | |
| A-2618 | Height 18 mm | In distribution |
| A-2413 | In distribution | |
| A-2813 | In distribution | |
| A-2416 | Width 24 mm | In distribution |
| A-2714 | Height 14 mm | In distribution |
| A-2613 | In distribution | |
| A-2918 | Width 29 mm | In distribution |
| 873-1408-0 | In distribution | |
| A-2910 | Width 29 mm | In distribution |
| EP-022 | In distribution | |
| A-2614 | Depth 36 mm | In distribution |
| EP-011 | In distribution | |
| A-2818 | Angle 8 ° | In distribution |
| A-2816 | Height 16 mm | In distribution |
| A-2712 | Angle 14 ° | In distribution |
| EP-013 | In distribution | |
| A-2912 | Height 12 mm | In distribution |
| EP-012 | In distribution | |
| A-2414 | Width 24 mm | In distribution |
| A-2412 | Depth 30 mm | In distribution |
| A-2516 | Depth 30 mm | In distribution |
| A-2513 | In distribution | |
| DP-002 | In distribution | |
| EP-006 | In distribution | |
| EP-008 | In distribution | |
| A-2512 | Height 12 mm | In distribution |
| LDP-001 | In distribution | |
| A-1013 | In distribution | |
| A-2814 | Height 14 mm | In distribution |
| DP-001 | In distribution | |
| EP-005 | In distribution | |
| 830-1204-0M | In distribution | |
| A-2718 | Height 18 mm | In distribution |
| EP-009 | In distribution | |
| EP-016 | In distribution | |
| A-2713 | In distribution | |
| A-2710 | Width 28 mm | In distribution |
| EP-007 | In distribution | |
| A-2810 | Angle 8 ° | In distribution |
| DP-006 | In distribution | |
| 10-0016 | In distribution | |
| EP-001 | In distribution | |
| EP-002 | In distribution | |
| EP-017 | In distribution | |
| EP-024 | In distribution | |
| A-2612 | Height 12 mm | In distribution |
| EP-025 | In distribution | |
| EP-026 | In distribution | |
| EP-014 | In distribution | |
| A-2812 | Depth 40 mm | In distribution |
| A-2913 | In distribution | |
| A-2518 | Angle 14 ° | In distribution |
| A-2410 | Height 10 mm | In distribution |
| A-2914 | Angle 14 ° | In distribution |
| DP-005 | In distribution | |
| EP-027 | In distribution | |
| A-1012 | In distribution | |
| EP-018 | In distribution | |
| A-2610 | Height 10 mm | In distribution |
| EP-020 | In distribution | |
| A-2514 | Depth 30 mm | In distribution |
| A-2510 | Angle 14 ° | In distribution |
| A-2418 | Height 18 mm | In distribution |
| EP-004 | In distribution | |
| A-2916 | Depth 40 mm | In distribution |
| EP-010 | In distribution | |
| A-1002 | In distribution | |
| A-2716 | Depth 36 mm | In distribution |
| DP-003 | In distribution | |
| DP-004 | In distribution | |
| EP-015 | 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
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.