Mini and Micro Fragments Reconstruction System – GMReis
MICRO VERSA SCREW TORXDRIVE TI Ø1.5x7.0mm MICRO VERSA SCREW TORXDRIVE TI Ø1.5x7.0mm
22manufacturers in China registered for this device type
169catalogue numbers in this listing
9510(k) clearances naming this product 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 | GM DOS Reis Industria E Comercio Ltda, Brazil |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2024-01-26 |
| Record revised | 2025-12-08 (version 6) |
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, expiry date, manufacturing date |
| Distribution end date | 2024-01-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Mini Y Plate | In distribution | |
| Baby Foot Plate | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Locking Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Baby Foot Plate | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Locking Screw | In distribution | |
| Locking Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Locking Screw | In distribution | |
| Mini and Micro Fragments Reconstruction System – GMReis | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Baby Foot Plate | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Y Plate | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| FLP Plate | In distribution | |
| Baby Foot Plate | In distribution | |
| Locking Screw | In distribution | |
| Locking Screw | In distribution | |
| Baby Foot Plate | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Locking Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Baby Foot Plate | In distribution | |
| Micro Screw | In distribution | |
| FLP Plate | In distribution | |
| Mini Cortical Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Baby Foot Plate | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Locking Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Locking Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Baby Foot Plate | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Micro Screw | In distribution | |
| Baby Foot Plate | In distribution | |
| Locking Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Locking Screw | In distribution | |
| Locking Screw | In distribution | |
| FLP Plate | In distribution | |
| Locking Screw | In distribution | |
| Mini Cortical Screw | In distribution | |
| Micro Screw | In distribution | |
| Locking Screw | In distribution | |
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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 |
|---|---|
| K262537 | 2026-08-19 |
| K261406 | 2026-07-21 |
| K260390 | 2026-03-17 |
| K243740 | 2025-01-29 |
| K242998 | 2024-11-21 |
| K242596 | 2024-11-21 |
| K232829 | 2024-06-26 |
| K231684 | 2024-01-12 |
| K201728 | 2021-03-08 |
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.