Signex
SIGNEX is a system of metallic plates and screws for bone fixation. The FDA filing describes use for fractures, fusions, osteotomies, non-unions, malunions, and reconstructions involving…
SIGNEX is a system of metallic plates and screws for bone fixation. The FDA filing describes use for fractures, fusions, osteotomies, non-unions, malunions, and reconstructions involving the upper or lower extremities and clavicle.
The filing identifies the plates as pure titanium or titanium alloy and the screws as titanium alloy. It states that the plates and screws are single-use products supplied non-sterile and must be sterile before use.
Use and Construction
The subject-device description identifies these components as bone-fixation plates and screws.
22manufacturers in China registered for this device type
1,310catalogue 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 | Osteonic Co., Ltd., South Korea |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K243469 |
| Record published | 2025-07-01 |
| Record revised | 2025-11-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Distribution end date | 2025-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S3F.45460 | In distribution | |
| B1J.27130 | In distribution | |
| L4A.35111 | In distribution | |
| S1E.50550 | In distribution | |
| D1D.22160 | In distribution | |
| S3H.50400 | In distribution | |
| S1H.37480 | In distribution | |
| S1B.28420 | In distribution | |
| C6.35580 | In distribution | |
| S1F.35320 | In distribution | |
| H3E.35020 | In distribution | |
| S1C.45460 | In distribution | |
| S3B.35240 | In distribution | |
| B1J.27090 | In distribution | |
| B2B.35031 | In distribution | |
| A2L.08060 | In distribution | |
| S1F.35400 | In distribution | |
| E1A.35030 | In distribution | |
| C1C.16430 | In distribution | |
| S1H.50140 | In distribution | |
| S1H.37680 | In distribution | |
| E2A.35170 | In distribution | |
| C7.24220 | In distribution | |
| S1B.28640 | In distribution | |
| K1E.50090 | In distribution | |
| L4B.50060 | In distribution | |
| S3H.50200 | In distribution | |
| S1D.28540 | In distribution | |
| A6.15150 | In distribution | |
| C1B.13320 | In distribution | |
| J3D.28050 | In distribution | |
| D2E.30380 | In distribution | |
| S3B.35380 | In distribution | |
| B1J.27260 | In distribution | |
| H1E.35180 | In distribution | |
| G3E.50130 | In distribution | |
| S1H.37525 | In distribution | |
| S1D.28450 | In distribution | |
| G3E.50070 | In distribution | |
| S1E.50450 | In distribution | |
| E1A.35110 | In distribution | |
| C6.28280 | In distribution | |
| S1B.35260 | In distribution | |
| B1B.22040 | In distribution | |
| G3F.50090 | In distribution | |
| B1B.28040 | In distribution | |
| J1G.24020 | In distribution | |
| C6.35150 | In distribution | |
| S1D.35340 | In distribution | |
| C6.35130 | In distribution | |
| S1B.28460 | In distribution | |
| C7.37560 | In distribution | |
| D2D.30450 | In distribution | |
| S3B.35280 | In distribution | |
| D2E.30200 | In distribution | |
| A2S.13070 | In distribution | |
| C5.35140 | In distribution | |
| J2G.35021 | In distribution | |
| S1F.35160 | In distribution | |
| E1A.35060 | In distribution | |
| S1D.35160 | In distribution | |
| D2E.30220 | In distribution | |
| H1D.35020 | In distribution | |
| S1B.35400 | In distribution | |
| C7.37540 | In distribution | |
| G3E.35060 | In distribution | |
| C5.28120 | In distribution | |
| C6.28400 | In distribution | |
| S1B.35460 | In distribution | |
| J2G.35071 | In distribution | |
| D2E.30270 | In distribution | |
| G3E.35010 | In distribution | |
| S1C.45360 | In distribution | |
| S1B.28320 | In distribution | |
| C1A.13270 | In distribution | |
| A5.23240 | In distribution | |
| A5.20070 | In distribution | |
| S1D.35700 | In distribution | |
| S3B.35460 | In distribution | |
| A5.23160 | In distribution | |
| A5.20090 | In distribution | |
| B1B.22020 | In distribution | |
| S1H.37400 | In distribution | |
| S1D.35750 | In distribution | |
| E2A.35200 | In distribution | |
| S3B.50360 | In distribution | |
| A6.23070 | In distribution | |
| C5.28240 | In distribution | |
| A3A.13080 | In distribution | |
| H3E.35040 | In distribution | |
| S1D.35600 | In distribution | |
| C6.35440 | In distribution | |
| C6.35520 | In distribution | |
| D2D.30360 | In distribution | |
| B1G.24141 | In distribution | |
| S1B.35150 | In distribution | |
| A1G.06060 | In distribution | |
| S1B.28540 | In distribution | |
| C6.28420 | In distribution | |
| S1C.45640 | In distribution | |
| S3H.50440 | In distribution | |
| L4C.50040 | In distribution | |
| A5.20150 | In distribution | |
| E1A.35050 | In distribution | |
| S1D.28260 | In distribution | |
| A6.23200 | In distribution | |
| S3F.45300 | In distribution | |
| A1A.06120 | In distribution | |
| S1B.50900 | In distribution | |
| G3F.35090 | In distribution | |
| C6.35120 | In distribution | |
| L4C.50100 | In distribution | |
| C5.28260 | In distribution | |
| S1F.35440 | In distribution | |
| C6.28320 | In distribution | |
| S1B.28580 | In distribution | |
| B1J.27100 | In distribution | |
| C5.35100 | In distribution | |
| D2E.30250 | In distribution | |
| C5.28170 | In distribution | |
| A5.25100 | In distribution | |
| S3F.45280 | In distribution | |
| G3H.50020 | In distribution | |
| J2G.35011 | In distribution | |
| S1C.45800 | In distribution | |
| S1D.35150 | In distribution | |
| A2A.10050 | In distribution | |
| A2B.08080 | In distribution | |
| F1H.35010 | In distribution | |
| C5.35160 | In distribution | |
| C6.35170 | In distribution | |
| C5.28200 | In distribution | |
| S3F.45240 | In distribution | |
| L4C.50170 | In distribution | |
| C5.28130 | In distribution | |
| C7.24160 | In distribution | |
| K1E.50100 | In distribution | |
| L2A.35150 | In distribution | |
| S1B.35190 | In distribution | |
| A6.15090 | In distribution | |
| S1B.50320 | In distribution | |
| B2A.35051 | In distribution | |
| C1B.16350 | In distribution | |
| G3F.50120 | In distribution | |
| A5.18070 | In distribution | |
| A5.25080 | In distribution | |
| G3F.35040 | In distribution | |
| A5.15170 | In distribution | |
| A2N.13060 | In distribution | |
| G3F.35180 | In distribution | |
| S1E.50900 | In distribution | |
| S1D.35240 | In distribution | |
| C6.28260 | In distribution | |
| S1C.45750 | In distribution | |
| A2E.08050 | In distribution | |
| S1H.37850 | In distribution | |
| C5.28100 | In distribution | |
| L2A.35170 | In distribution | |
| S1F.35520 | In distribution | |
| S1D.28580 | In distribution | |
| G1F.35090 | In distribution | |
| S1B.28360 | In distribution | |
| C5.35110 | In distribution | |
| A3N.13100 | In distribution | |
| A5.18060 | In distribution | |
| H1D..35070 | In distribution | |
| F1E.35160 | In distribution | |
| A5.20110 | In distribution | |
| G3F.35120 | In distribution | |
| A2L.10060 | In distribution | |
| B1D.29020 | In distribution | |
| S1C.45220 | In distribution | |
| A5.20220 | In distribution | |
| S1D.28110 | In distribution | |
| A2M.13060 | In distribution | |
| D1E.22400 | In distribution | |
| B2A.35031 | In distribution | |
| D2E.30300 | In distribution | |
| G3F.50050 | In distribution | |
| S1B.50400 | In distribution | |
| S3F.45520 | In distribution | |
| G1F.35040 | In distribution | |
| S1D.28440 | In distribution | |
| S1D.35100 | In distribution | |
| E1G.35090 | In distribution | |
| J2G.35012 | In distribution | |
| S1H.50110 | In distribution | |
| S1B.28280 | In distribution | |
| A6.23170 | In distribution | |
| L3A.35111 | In distribution | |
| H1D.35080 | In distribution | |
| C5.35200 | In distribution | |
| G1F.35150 | In distribution | |
| H1D.35110 | In distribution | |
| D2D.30400 | In distribution | |
| A6.20280 | In distribution | |
| A2C.08060 | In distribution | |
| C7.30280 | In distribution | |
| C1C.16250 | In distribution | |
| S3B.35140 | In distribution | |
| A2H.08080 | In distribution | |
| A5.20080 | In distribution | |
| B1B.24020 | In distribution | |
| A5.23200 | In distribution | |
| S1H.50950 | In distribution | |
| S1H.50120 | In distribution | |
| K1H.50030 | In distribution | |
| S1D.35140 | In distribution | |
| B1B.22030 | In distribution | |
| C6.35500 | In distribution | |
| L2A.35130 | In distribution | |
| D2D.30120 | In distribution | |
| D1D.22260 | In distribution | |
| B1B.22060 | In distribution | |
| S1D.35180 | In distribution | |
| S1H.50105 | In distribution | |
| H1D.35040 | In distribution | |
| B1B.28070 | In distribution | |
| E2A.35130 | In distribution | |
| S1B.50450 | In distribution | |
| S1B.28130 | In distribution | |
| D1D.22280 | In distribution | |
| A6.23120 | In distribution | |
| F1E.35100 | In distribution | |
| L3A.35011 | In distribution | |
| S1D.35440 | In distribution | |
| F1E.35030 | In distribution | |
| S1C.45240 | In distribution | |
| B1G.24180 | In distribution | |
| A6.15130 | In distribution | |
| S1B.35540 | In distribution | |
| K1E.50060 | In distribution | |
| D2D.30160 | In distribution | |
| A5.23150 | In distribution | |
| E1G.35120 | In distribution | |
| A5.13100 | In distribution | |
| C6.35450 | In distribution | |
| C5.35280 | In distribution | |
| S1H.37560 | In distribution | |
| S1C.45650 | In distribution | |
| K1H.50020 | In distribution | |
| F1E.35040 | In distribution | |
| A1H.06080 | In distribution | |
| S1D.35420 | In distribution | |
| B1J.27300 | In distribution | |
| L4A.35021 | In distribution | |
| S1D.28200 | In distribution | |
| S1H.50550 | In distribution | |
| D1D.22300 | In distribution | |
| D2D.30130 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| LCP | Synthes Gmbh | 1,295 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243469 | 2025-05-29 |
| K230546 | 2024-06-11 |
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.