OsteoMed
ICON, 4 Hole Fracture Plate, Locking, Medium, 1.5mm Thick, TEMPLATE
3manufacturers in China registered for this device type
1,295catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Dentalmaster (Xiamen) Medical Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 1 |
Record
| Listed by | Osteomed, United States |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-04-01 |
| Record revised | 2022-09-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store at controlled room temperature out of direct sunlight |
| Sizes | Length 2 to 300 mm; outer diameter 0.9 to 31 mm; length 0.818 to 8 in; height 0.9 to 16 mm; angle 140 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 210-0024 | Length 18 mm | In distribution |
| 220-0641-36 | In distribution | |
| 303-1206 | Length 6 mm | In distribution |
| 222-0006 | In distribution | |
| 210-0036 | Length 22 mm | In distribution |
| 208-1608-SP | Length 8 mm | In distribution |
| 218-0093 | Length 18 mm | In distribution |
| 305-2416 | Length 16 mm | In distribution |
| 213-0029 | Length 29 mm | In distribution |
| 213-0045 | Length 10 mm | In distribution |
| 220-0319-SP-02 | In distribution | |
| 220-0640-25 | In distribution | |
| 210-0005 | Length 20 mm | In distribution |
| 220-0620-02 | In distribution | |
| 218-2001-SP | Length 42 mm | In distribution |
| 218-2004 | Length 89 mm | In distribution |
| 210-0091 | Length 17 mm | In distribution |
| 220-0643-30 | In distribution | |
| 220-0743 | In distribution | |
| 214-0214 | Length 49 mm | In distribution |
| 208-1605 | Length 5 mm | In distribution |
| 212-0032-SP-02 | Length 17 mm | In distribution |
| 232-2708 | Length 8 mm | In distribution |
| 210-0206-SP-05 | Length 16 mm | In distribution |
| 220-0062 | In distribution | |
| 220-0640-157 | In distribution | |
| 210-1026 | Length 124 mm | In distribution |
| 111-1250 | Outer Diameter 1.2 mm | In distribution |
| 210-1041 | Length 50 mm | In distribution |
| 220-0643-25 | In distribution | |
| 305-2410 | Length 10 mm | In distribution |
| 213-0008 | Length 14 mm | In distribution |
| 210-0309 | Height 0.9 mm | In distribution |
| 204-1206-SP | Length 6 mm | In distribution |
| 220-0641-27 | In distribution | |
| 214-0265-SP-02 | Thickness = 2.5mm | In distribution |
| 207-2414 | Length 14 mm | In distribution |
| 210-1032 | Length 46 mm | In distribution |
| 208-2014 | Length 14 mm | In distribution |
| 214-2021 | Length 33 mm | In distribution |
| 220-0643-85 | In distribution | |
| 220-0644-45 | In distribution | |
| 212-0080 | Length 33 mm | In distribution |
| 210-0301 | Span Length = 5mm | In distribution |
| 214-2024 | Length 33 mm | In distribution |
| 210-0216-SP-05 | Length 24 mm | In distribution |
| 218-0020 | Length 13 mm | In distribution |
| 220-0640-76 | In distribution | |
| 301-2018 | Length 18 mm | In distribution |
| 220-0361 | In distribution | |
| 234-2004 | Length 4 mm | In distribution |
| 214-0084-SP | Length 25 mm | In distribution |
| 111-1260 | Outer Diameter 1.2 mm | In distribution |
| 250-1608-SP | Length 8 mm | In distribution |
| 210-0300 | Span Length = 5mm | In distribution |
| 232-2406 | Length 6 mm | In distribution |
| 220-0720 | In distribution | |
| 220-0644-20 | In distribution | |
| 210-1059 | Length 47 mm | In distribution |
| 220-0640-77 | In distribution | |
| 310-4006 | Length 37 mm | In distribution |
| 218-0078-SP | In distribution | |
| 213-0026 | Length 12 mm | In distribution |
| 210-0041 | Advancement = 2mm | In distribution |
| 208-1610-SP | Length 10 mm | In distribution |
| 212-0038-SP-02 | Length 21 mm | In distribution |
| 214-0201T | Length 142 mm | In distribution |
| 216-1608 | Length 8 mm | In distribution |
| 234-2324 | Length 24 mm | In distribution |
| 214-0202 | Thickness = 2.5mm | In distribution |
| 213-0019-SP-02 | Length 44 mm | In distribution |
| 213-0126 | Length 14 mm | In distribution |
| 210-0111-SP-02 | Thickness = 0.9mm | In distribution |
| 220-0641-21 | In distribution | |
| 214-0094-SP-02 | Length 35 mm | In distribution |
| 299-2011 | Length 11 mm | In distribution |
| 210-0112-SP | Length 47 mm | In distribution |
| 220-0640-92 | In distribution | |
| 220-0640-100 | In distribution | |
| 214-0102 | Length 116 mm | In distribution |
| 210-0235 | Length 16 mm | In distribution |
| 210-1048 | Length 31 mm | In distribution |
| 224-0032 | Height 11 mm | In distribution |
| 220-0640-48 | In distribution | |
| 232-2710 | Length 10 mm | In distribution |
| 220-0620-06 | In distribution | |
| 210-1064 | Length 23 mm | In distribution |
| 220-0620-05 | In distribution | |
| 213-0009-SP-02 | Length 14 mm | In distribution |
| 220-0641-33 | In distribution | |
| 202-2016 | Length 16 mm | In distribution |
| 213-1635 | Length 28 mm | In distribution |
| 204-1204 | Length 4 mm | In distribution |
| 214-0215 | Length 52 mm | In distribution |
| 220-0640-17 | In distribution | |
| 220-0644-25 | In distribution | |
| 220-0613-08 | In distribution | |
| 214-0080 | Length 32 mm | In distribution |
| 212-0032 | Length 17 mm | In distribution |
| 234-2018 | Length 18 mm | In distribution |
| 209-2008 | Length 8 mm | In distribution |
| 250-1604-SP | Length 4 mm | In distribution |
| 111-1651 | Outer Diameter 1.6 mm | In distribution |
| 220-0613-14 | In distribution | |
| 213-1616 | Length 30 mm | In distribution |
| 222-0206 | In distribution | |
| 202-2014-SP-10 | Length 14 mm | In distribution |
| 222-0205 | In distribution | |
| 213-1606 | Length 36 mm | In distribution |
| 214-0266 | Thickness = 2.5mm | In distribution |
| 220-0641-23 | In distribution | |
| 220-0115 | In distribution | |
| 220-0641-08 | In distribution | |
| 210-1052 | Length 30 mm | In distribution |
| 210-0090 | Length 17 mm | In distribution |
| 210-0232 | Length 54 mm | In distribution |
| 220-0640-120 | In distribution | |
| 218-2015 | Length 92 mm | In distribution |
| 214-0206T | Length 215 mm | In distribution |
| 218-2006-SP | Length 89 mm | In distribution |
| 202-2012-SP-10 | Length 12 mm | In distribution |
| 210-0150-SP | Length 18 mm | In distribution |
| 218-2002 | Length 43 mm | In distribution |
| 220-0089 | In distribution | |
| 213-0031 | Length 80 mm | In distribution |
| 220-0620-04 | In distribution | |
| 220-0614-99 | In distribution | |
| 220-0720-04 | In distribution | |
| 222-0007 | In distribution | |
| 301-2008 | Length 8 mm | In distribution |
| 202-2016-SP | Length 16 mm | In distribution |
| 220-0641-18 | In distribution | |
| 220-0644-09 | In distribution | |
| 218-0090-SP-05 | Length 13 mm | In distribution |
| 111-0951 | Outer Diameter 0.9 mm | In distribution |
| 210-0081 | Length 31 mm | In distribution |
| 312-2243 | Length 18 mm | In distribution |
| 220-0640-118 | In distribution | |
| 218-0048 | Length 37 mm | In distribution |
| 213-0028 | Length 29 mm | In distribution |
| 220-0640-37 | In distribution | |
| 214-0266-SP-02 | Thickness = 2.5mm | In distribution |
| 220-0641-25 | In distribution | |
| 220-0640-75 | In distribution | |
| 214-0211 | Length 34 mm | In distribution |
| 209-1904 | Length 4 mm | In distribution |
| 210-0214-SP | Length 24 mm | In distribution |
| 210-1046 | Length 23 mm | In distribution |
| 210-0210 | Length 19 mm | In distribution |
| 210-0004 | Length 15 mm | In distribution |
| 312-2203 | Length 17 mm | In distribution |
| 204-1503 | Length 3 mm | In distribution |
| 210-0010-SP | Length 18 mm | In distribution |
| 220-0641-03 | In distribution | |
| 220-0640-101 | In distribution | |
| 220-0620-01 | In distribution | |
| 212-0039-SP-02 | Length 33 mm | In distribution |
| 220-0106 | In distribution | |
| 220-0643-24 | In distribution | |
| 232-2416 | Length 16 mm | In distribution |
| 111-0981 | Outer Diameter 0.9 mm | In distribution |
| 214-0216 | Length 59 mm | In distribution |
| 213-0115 | Length 25 mm | In distribution |
| 206-2420-SP-02 | Length 20 mm | In distribution |
| 206-2418-SP-05 | Length 18 mm | In distribution |
| 220-0019 | In distribution | |
| 213-0027 | Length 12 mm | In distribution |
| 220-0256 | In distribution | |
| 230-0025 | Length 6 in | In distribution |
| 204-1206-SP-10 | Length 6 mm | In distribution |
| 210-0302-SP-05 | Span Length = 8mm | In distribution |
| 310-3004 | Length 25 mm | In distribution |
| 218-0070-SP | In distribution | |
| 214-0206 | Thickness = 2.5mm | In distribution |
| 214-0050 | Length 33 mm | In distribution |
| 204-1208 | Length 8 mm | In distribution |
| 214-0207T | Length 138 mm | In distribution |
| 216-1614 | Length 14 mm | In distribution |
| 310-2404 | Length 36 mm | In distribution |
| 210-0214-SP-05 | Length 24 mm | In distribution |
| 214-0115-SP | Length 48 mm | In distribution |
| 206-2418 | Length 18 mm | In distribution |
| 210-1020 | Length 124 mm | In distribution |
| 218-0082-SP-05 | Length 17 mm | In distribution |
| 214-0261-SP-02 | Thickness = 2.5mm | In distribution |
| 220-0526 | In distribution | |
| 218-0095-SP-10 | Outer Diameter 26 mm | In distribution |
| 210-0216-SP | Length 24 mm | In distribution |
| 220-0644-26 | In distribution | |
| 210-1055 | Length 46 mm | In distribution |
| 254-2004-SP | Length 4 mm | In distribution |
| 210-0030 | Length 24 mm | In distribution |
| 210-0307 | Span Length = 13mm | In distribution |
| 231-1513 | Length 52 mm | In distribution |
| 210-1022 | Length 124 mm | In distribution |
| 213-0009 | Length 14 mm | In distribution |
| 218-0022 | Length 9 mm | In distribution |
| 216-1612 | Length 12 mm | In distribution |
| 212-0036 | Length 47 mm | In distribution |
| 212-0043 | Length 99 mm | In distribution |
| 111-1641 | Outer Diameter 1.6 mm | In distribution |
| 209-2011 | Length 11 mm | In distribution |
| 220-0640-15 | In distribution | |
| 210-0020 | Length 13 mm | In distribution |
| 220-0641-34 | In distribution | |
| 210-0110 | Length 37 mm | In distribution |
| 210-0305 | Span Length = 12mm | In distribution |
| 214-0382 | Length 34 mm | In distribution |
| 209-2008-SP | Length 8 mm | In distribution |
| 232-2716 | Length 16 mm | In distribution |
| 206-2718 | Length 18 mm | In distribution |
| 212-0144 | Outer Diameter 16 mm | In distribution |
| 220-0704 | In distribution | |
| 210-1047 | Length 27 mm | In distribution |
| 210-1030 | Length 22 mm | In distribution |
| 214-0082-SP-05 | Length 33 mm | In distribution |
| 218-0081 | Length 13 mm | In distribution |
| 214-0212 | Length 37 mm | In distribution |
| 214-0114-SP-02 | Length 45 mm | In distribution |
| 210-1065 | Length 27 mm | In distribution |
| 314-2124 | Length 40 mm | In distribution |
| 220-0641-05 | In distribution | |
| 213-1601 | Length 22 mm | In distribution |
| 254-1604-SP | Length 4 mm | In distribution |
| 220-0740 | In distribution | |
| 220-0640-09 | In distribution | |
| 213-1607 | Length 12 mm | In distribution |
| 218-4502 | Length 8 in | In distribution |
| 220-0640-96 | In distribution | |
| 214-0052 | Length 48 mm | In distribution |
| 231-1502 | Length 34 mm | In distribution |
| 210-0232-SP-05 | Length 54 mm | In distribution |
| 213-0123 | Length 10 mm | In distribution |
| 111-0950 | Outer Diameter 0.9 mm | In distribution |
| 212-0041 | Length 17 mm | In distribution |
| 213-0124 | Length 12 mm | In distribution |
| 220-0092 | In distribution | |
| 210-0022-SP | Length 13 mm | In distribution |
| 305-2422 | Length 22 mm | In distribution |
| 220-0547 | In distribution | |
| 208-1606-SP-10 | Length 6 mm | In distribution |
| 220-0640-122 | In distribution | |
| 212-1030-SP-05 | Length 16 mm | In distribution |
| 301-2012 | Length 12 mm | In distribution |
| 220-0641-09 | In distribution | |
| 214-0386-SP-02 | Length 39 mm | In distribution |
| 111-1241 | Outer Diameter 1.2 mm | In distribution |
| 213-0011 | Length 45 mm | In distribution |
| 220-0254 | In distribution | |
| 214-0109 | Length 33 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Faico CMF System | Faico Medical, LLC | 540 |
| Neoface | Neoortho Produtos Ortopédicos S/A | 181 |
| CMF Visionare | Visionare LLC | 155 |
| Universal Mandible AXS | Stryker Leibinger Gmbh & Co. KG | 148 |
| Tandry CMF Plate System | Microware Precision Co., Ltd. | 140 |
| Screw, Fixation, Intraosseous | Synthes Gmbh | 132 |
| Level ONE CMF | KLS-Martin L.P. | 71 |
| MatrixMIDFACE | Synthes Gmbh | 65 |
| PlusDrive | Synthes Gmbh | 52 |
| Universal 2.0 MP AXS | Stryker Leibinger Gmbh & Co. KG | 51 |
| MCI – Medical Concept Innovation, Inc. | MCI Medical Concept Innovation Inc. | 49 |
| CMF | Southern Medical (PTY) Ltd | 37 |
Showing 12 of 92. All products under Screw, Fixation, Intraosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151195 | 2015-09-21 |
| K012486 | 2002-01-16 |
| K962774 | 1997-10-10 |
| K961418 | 1996-10-25 |
| K911936 | 1991-08-21 |
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.