SMV Scientific Non-Locking Plate
169mm, Nonlocking Straight Reconstruction Plate
22manufacturers in China registered for this device type
91catalogue numbers in this listing
2510(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 | OsteoCentric Technologies,Inc, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2017-02-10 |
| Record revised | 2025-11-20 (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 |
| Sizes | Length 21 to 288 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 302-9118 | Length 118 mm | In distribution |
| 304-13169 | Length 169 mm | In distribution |
| 302-15194 | Length 194 mm | In distribution |
| 303-339 | Length 39 mm | In distribution |
| 302-340 | Length 40 mm | In distribution |
| 301-333 | Length 33 mm | In distribution |
| 303-11135 | Length 135 mm | In distribution |
| 302-16207 | Length 207 mm | In distribution |
| 302-21272 | Length 272 mm | In distribution |
| 302-12157 | Length 157 mm | In distribution |
| 302-16209 | Length 209 mm | In distribution |
| 301-9105 | Length 105 mm | In distribution |
| 304-22288 | Length 288 mm | In distribution |
| 302-12155 | Length 155 mm | In distribution |
| 304-339 | Length 39 mm | In distribution |
| 304-17221 | Length 221 mm | In distribution |
| 301-12141 | Length 141 mm | In distribution |
| 302-8105 | Length 105 mm | In distribution |
| 303-12147 | Length 147 mm | In distribution |
| 303-221 | Length 21 mm | In distribution |
| 304-14182 | Length 182 mm | In distribution |
| 301-557 | Length 57 mm | In distribution |
| 302-227 | Length 27 mm | In distribution |
| 302-451 | Length 51 mm | In distribution |
| 304-21273 | Length 273 mm | In distribution |
| 303-675 | Length 75 mm | In distribution |
| 303-9105 | Length 105 mm | In distribution |
| 303-9111 | Length 111 mm | In distribution |
| 304-15195 | Length 195 mm | In distribution |
| 302-453 | Length 53 mm | In distribution |
| 302-14183 | Length 183 mm | In distribution |
| 304-16210 | Length 210 mm | In distribution |
| 304-21275 | Length 275 mm | In distribution |
| 304-567 | Length 67 mm | In distribution |
| 302-19246 | Length 246 mm | In distribution |
| 301-445 | Length 45 mm | In distribution |
| 303-451 | Length 51 mm | In distribution |
| 302-11142 | Length 142 mm | In distribution |
| 302-566 | Length 66 mm | In distribution |
| 303-12141 | Length 141 mm | In distribution |
| 302-20259 | Length 259 mm | In distribution |
| 302-14181 | Length 181 mm | In distribution |
| 304-19247 | Length 247 mm | In distribution |
| 304-9119 | Length 119 mm | In distribution |
| 302-338 | Length 38 mm | In distribution |
| 304-8106 | Length 106 mm | In distribution |
| 304-13171 | Length 171 mm | In distribution |
| 304-12158 | Length 158 mm | In distribution |
| 304-20262 | Length 262 mm | In distribution |
| 304-20260 | Length 260 mm | In distribution |
| 302-11144 | Length 144 mm | In distribution |
| 302-679 | Length 79 mm | In distribution |
| 304-19249 | Length 249 mm | In distribution |
| 304-18234 | Length 234 mm | In distribution |
| 302-10131 | Length 131 mm | In distribution |
| 301-669 | Length 69 mm | In distribution |
| 302-18233 | Length 233 mm | In distribution |
| 301-781 | Length 81 mm | In distribution |
| 304-680 | Length 80 mm | In distribution |
| 304-18236 | Length 236 mm | In distribution |
| 304-14184 | Length 184 mm | In distribution |
| 304-17223 | Length 223 mm | In distribution |
| 304-12156 | Length 156 mm | In distribution |
| 303-333 | Length 33 mm | In distribution |
| 303-227 | Length 27 mm | In distribution |
| 302-13168 | Length 168 mm | In distribution |
| 303-899 | Length 99 mm | In distribution |
| 304-10132 | Length 132 mm | In distribution |
| 303-787 | Length 87 mm | In distribution |
| 301-221 | Length 21 mm | In distribution |
| 304-10130 | Length 130 mm | In distribution |
| 303-345 | Length 45 mm | In distribution |
| 302-225 | Length 25 mm | In distribution |
| 302-792 | Length 92 mm | In distribution |
| 304-793 | Length 93 mm | In distribution |
| 302-22285 | Length 285 mm | In distribution |
| 302-15196 | Length 196 mm | In distribution |
| 304-11143 | Length 143 mm | In distribution |
| 302-13170 | Length 170 mm | In distribution |
| 301-893 | Length 93 mm | In distribution |
| 304-22286 | Length 286 mm | In distribution |
| 304-452 | Length 52 mm | In distribution |
| 304-16208 | Length 208 mm | In distribution |
| 301-10117 | Length 117 mm | In distribution |
| 303-10123 | Length 123 mm | In distribution |
| 304-454 | Length 54 mm | In distribution |
| 304-15197 | Length 197 mm | In distribution |
| 303-11129 | Length 129 mm | In distribution |
| 303-563 | Length 63 mm | In distribution |
| 304-11145 | Length 145 mm | In distribution |
| 302-17220 | Length 220 mm | 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 |
|---|---|
| K251913 | 2025-08-16 |
| K250494 | 2025-03-18 |
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.