Leos
LEOS Straight Plate, 2 Hole, CMP, Med
22manufacturers in China registered for this device type
45catalogue numbers in this listing
11510(k) clearances naming this product code
20recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Tyber Medical, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K222465 |
| Record published | 2022-10-04 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7622-0250 | In distribution | |
| 7622-0350 | In distribution | |
| 7622-0060 | In distribution | |
| 7622-1050 | In distribution | |
| 7622-1003 | In distribution | |
| 7622-0020 | In distribution | |
| 7622-0230 | In distribution | |
| 7622-1053 | In distribution | |
| 7622-0141 | In distribution | |
| 7622-1051 | In distribution | |
| 7622-2081 | In distribution | |
| 7622-1250 | In distribution | |
| 7622-0331 | In distribution | |
| 7622-0023 | In distribution | |
| 7622-0140 | In distribution | |
| 7622-2041 | In distribution | |
| 7622-0021 | In distribution | |
| 7622-2000 | In distribution | |
| 7622-1052 | In distribution | |
| 7622-3231 | In distribution | |
| 7622-1002 | In distribution | |
| 7622-1000 | In distribution | |
| 7622-0351 | In distribution | |
| 7622-1001 | In distribution | |
| 7622-2200 | In distribution | |
| 7622-0451 | In distribution | |
| 7622-2040 | In distribution | |
| 7622-0431 | In distribution | |
| 7622-3123 | In distribution | |
| 7622-1252 | In distribution | |
| 7622-3122 | In distribution | |
| 7622-0450 | In distribution | |
| 7622-0040 | In distribution | |
| 7622-0024 | In distribution | |
| 7622-1251 | In distribution | |
| 7622-0022 | In distribution | |
| 7622-3121 | In distribution | |
| 7622-3230 | In distribution | |
| 7622-0430 | In distribution | |
| 7622-2001 | In distribution | |
| 7622-0030 | In distribution | |
| 7622-1253 | In distribution | |
| 7622-3120 | In distribution | |
| 7622-2080 | In distribution | |
| 7622-0330 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261207 | 2026-06-12 |
| K251361 | 2025-07-30 |
| K242486 | 2025-03-19 |
| K241218 | 2024-05-31 |
| K233423 | 2023-12-21 |
| K233017 | 2023-12-20 |
| K232652 | 2023-12-13 |
| K232693 | 2023-12-04 |
| K222465 | 2023-03-07 |
| K203817 | 2021-08-13 |
| K193222 | 2020-01-20 |
Recalls
20 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 |
|---|---|---|---|---|
| 2025-12-19 | Class II | Process control | The supplier manufactured anatomical left plates with an incorrect thread orientation. | 100 units |
| 2025-12-19 | Class II | Process control | The supplier manufactured anatomical left plates with an incorrect thread orientation. | 64 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 408 |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 200 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 212 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 412 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 201 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 109 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 418 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 100 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 219 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 214 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 208 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 397 |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 197 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 100 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 115 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 209 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 220 units |
| 2025-01-21 | Class II | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | 210 units |
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.