OsteoMed
4.2 mm Cannulated Proximal Cortex Drill, Standard AO Quick Release , Sterile, 2 Pk
31manufacturers in China registered for this device type
2,764catalogue numbers in this listing
12510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Osteomed, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-07-21 |
| Record revised | 2022-09-16 (version 8) |
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: Implants and instruments should be stored out of direct sunlight; Handling environment temperature up to 275 °F |
| Sizes | Length 3 to 196 mm; outer diameter 1 to 12.4 mm; outer diameter 0.028 to 2.9 in; length 2.88 to 17.94 in; lumen/inner diameter 4.5 to 7 mm; lumen/inner diameter 0.086 to 0.125 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 395-4002-24 | In distribution | |
| 359-2722-SP-02 | Length 22 mm | In distribution |
| 359-2418 | Length 18 mm | In distribution |
| 358-2712 | Length 12 mm | In distribution |
| 358-2720-SP-05 | Length 20 mm | In distribution |
| 315-2026 | Length 26 mm | In distribution |
| 318-3014 | Length 14 mm | In distribution |
| 317-6585-SP-02 | Length 85 mm | In distribution |
| 358-2430 | Length 30 mm | In distribution |
| 331-2024 | Length 24 mm | In distribution |
| 334-2024-SP-02 | Length 24 mm | In distribution |
| 319-6545-SP-02 | Length 45 mm | In distribution |
| 317-4040-SP-05 | Length 40 mm | In distribution |
| 339-5540 | Length 40 mm | In distribution |
| 318-3026 | Length 26 mm | In distribution |
| 302-2008-SP-05 | Length 8 mm | In distribution |
| 345-5535 | Length 35 mm | In distribution |
| 330-2014-SP-05 | Length 14 mm | In distribution |
| 345-6555-SP-02 | Length 55 mm | In distribution |
| 316-0105 | In distribution | |
| 319-6600 | Length 100 mm | In distribution |
| 319-5543 | Length 42 mm | In distribution |
| 359-2740 | Length 40 mm | In distribution |
| 302-2014 | Length 14 mm | In distribution |
| 359-2415-SP-05 | Length 15 mm | In distribution |
| 317-6555-SP-02 | Length 55 mm | In distribution |
| 315-4020 | Length 20 mm | In distribution |
| 354-1822-SP-05 | Length 22 mm | In distribution |
| 359-2730 | Length 30 mm | In distribution |
| 349-2432-SP-02 | Length 32 mm | In distribution |
| 341-1008 | Length 8 mm | In distribution |
| 345-4575-SP-02 | Length 75 mm | In distribution |
| 339-5524 | Length 24 mm | In distribution |
| 319-0770 | Length 70 mm | In distribution |
| 317-0751 | Length 50 mm | In distribution |
| 315-2426 | Length 26 mm | In distribution |
| 319-2028-SP-05 | Length 28 mm | In distribution |
| 306-2430 | Length 30 mm | In distribution |
| 319-4551-SP-02 | Length 50 mm | In distribution |
| 358-2440 | Length 40 mm | In distribution |
| 315-2013 | Length 13 mm | In distribution |
| 317-6590-SP-02 | Length 90 mm | In distribution |
| 319-0786-SP-02 | Length 85 mm | In distribution |
| 359-2730-SP-02 | Length 30 mm | In distribution |
| 319-4024-SP-05 | Length 24 mm | In distribution |
| 319-4536-SP-02 | Length 36 mm | In distribution |
| 317-2428-SP-05 | Length 28 mm | In distribution |
| 354-1834-SP-05 | Length 34 mm | In distribution |
| 339-4528-SP-02 | Length 28 mm | In distribution |
| 317-4052 | Length 52 mm | In distribution |
| 317-5538-SP-05 | Length 38 mm | In distribution |
| 319-7051 | Length 52 mm | In distribution |
| 330-1611-SP-05 | Length 11 mm | In distribution |
| 331-2028 | Length 28 mm | In distribution |
| 339-5546-SP-02 | Length 46 mm | In distribution |
| 319-3032-SP-05 | Length 32 mm | In distribution |
| 339-6580-SP-02 | Length 80 mm | In distribution |
| 319-6116-SP | Length 115 mm | In distribution |
| 316-1708 | Outer Diameter 6 mm | In distribution |
| 317-5534-SP-05 | Length 34 mm | In distribution |
| 319-6115-SP-02 | Length 115 mm | In distribution |
| 211-1605 | Length 5 mm | In distribution |
| 331-2026 | Length 26 mm | In distribution |
| 339-5550 | Length 50 mm | In distribution |
| 319-2013 | Length 13 mm | In distribution |
| 316-1801 | In distribution | |
| 308-3028-SP-05 | Length 28 mm | In distribution |
| 359-2732 | Length 32 mm | In distribution |
| 339-4526 | Length 26 mm | In distribution |
| 319-7066-SP-02 | Length 52 mm | In distribution |
| 330-2413-SP-05 | Length 13 mm | In distribution |
| 317-5555-SP-02 | Length 55 mm | In distribution |
| 319-7100-SP | Length 52 mm | In distribution |
| 319-6590 | Length 90 mm | In distribution |
| 345-5565-SP-02 | Length 65 mm | In distribution |
| 319-4538 | Length 38 mm | In distribution |
| 319-3036 | Length 36 mm | In distribution |
| 317-5526-SP-02 | Length 26 mm | In distribution |
| 319-7086-SP | Length 52 mm | In distribution |
| 317-5524-SP-02 | Length 24 mm | In distribution |
| 320-1413 | Outer Diameter 1.3 mm | In distribution |
| 319-7085-SP | Length 52 mm | In distribution |
| 358-2418 | Length 18 mm | In distribution |
| 319-3026 | Length 26 mm | In distribution |
| 334-2026 | Length 26 mm | In distribution |
| 359-2440-SP-02 | Length 40 mm | In distribution |
| 319-5542-SP-02 | Length 42 mm | In distribution |
| 331-1209-SP-05 | Length 9 mm | In distribution |
| 339-4540 | Length 40 mm | In distribution |
| 319-7100-SP-02 | Length 52 mm | In distribution |
| 317-4545 | Length 44 mm | In distribution |
| 331-2420 | Length 20 mm | In distribution |
| 320-1520 | In distribution | |
| 317-4556-SP-02 | Length 55 mm | In distribution |
| 331-2016-SP-05 | Length 16 mm | In distribution |
| 331-1608 | Length 8 mm | In distribution |
| 318-2406 | Length 6 mm | In distribution |
| 330-1612-SP-05 | Length 12 mm | In distribution |
| 359-2734 | Length 34 mm | In distribution |
| 330-2011 | Length 11 mm | In distribution |
| 320-1011 | In distribution | |
| 319-2024-SP-05 | Length 24 mm | In distribution |
| 317-4044 | Length 44 mm | In distribution |
| 349-2413 | Length 13 mm | In distribution |
| 317-4550-SP-02 | Length 50 mm | In distribution |
| 334-2428-SP-02 | Length 28 mm | In distribution |
| 319-0806-SP-02 | Length 105 mm | In distribution |
| 316-1503 | Length 9.24 in | In distribution |
| 318-2428 | Length 28 mm | In distribution |
| 316-0002-SP-02 | Length 5 in | In distribution |
| 302-2010 | Length 10 mm | In distribution |
| 319-6605-SP-02 | Length 105 mm | In distribution |
| 315-2020 | Length 20 mm | In distribution |
| 318-2414 | Length 14 mm | In distribution |
| 306-2406-SP-05 | Length 6 mm | In distribution |
| 317-2024-SP-05 | Length 24 mm | In distribution |
| 380-0012 | Length 178 mm | In distribution |
| 317-5538 | Length 38 mm | In distribution |
| 306-2430-SP-05 | Length 30 mm | In distribution |
| 319-6606-SP-02 | Length 105 mm | In distribution |
| 331-2014 | Length 14 mm | In distribution |
| 319-6555 | Length 55 mm | In distribution |
| 317-4546 | Length 46 mm | In distribution |
| 316-1710 | In distribution | |
| 320-2704 | Lumen/Inner Diameter 0.086 in | In distribution |
| 319-6605 | Length 105 mm | In distribution |
| 319-2446 | Length 46 mm | In distribution |
| 319-6101-SP | Length 100 mm | In distribution |
| 308-3022-SP-05 | Length 22 mm | In distribution |
| 319-7060 | Length 52 mm | In distribution |
| 306-2416-SP | Length 16 mm | In distribution |
| 345-6565-SP-02 | Length 65 mm | In distribution |
| 320-2770 | In distribution | |
| 320-4040 | In distribution | |
| 334-2020-SP-02 | Length 20 mm | In distribution |
| 359-2421 | Length 21 mm | In distribution |
| 332-1213 | Length 13 mm | In distribution |
| 317-4038-SP-05 | Length 38 mm | In distribution |
| 354-1832-SP-02 | Length 32 mm | In distribution |
| 359-2413-SP-02 | Length 13 mm | In distribution |
| 317-4540-SP-05 | Length 40 mm | In distribution |
| 306-2422-SP-05 | Length 22 mm | In distribution |
| 315-4028 | Length 28 mm | In distribution |
| 318-3012 | Length 12 mm | In distribution |
| 358-2426-SP-02 | Length 26 mm | In distribution |
| 319-2410 | Length 10 mm | In distribution |
| 319-7096 | Length 52 mm | In distribution |
| 317-4012 | Length 12 mm | In distribution |
| 319-4528 | Length 28 mm | In distribution |
| 317-6570 | Length 70 mm | In distribution |
| 308-1624-SP-05 | Length 24 mm | In distribution |
| 319-0795 | Length 95 mm | In distribution |
| 317-3020 | Length 20 mm | In distribution |
| 349-2414-SP-05 | Length 14 mm | In distribution |
| 319-5544 | Length 44 mm | In distribution |
| 358-2716-SP-02 | Length 16 mm | In distribution |
| 330-2409 | Length 9 mm | In distribution |
| 349-2420-SP-05 | Length 20 mm | In distribution |
| 302-2011-SP-05 | Length 11 mm | In distribution |
| 211-2006-SP-03 | Length 6 mm | In distribution |
| 349-2422 | Length 22 mm | In distribution |
| 317-0781 | Length 80 mm | In distribution |
| 358-2722-SP-02 | Length 22 mm | In distribution |
| 319-6071-SP | Length 70 mm | In distribution |
| 306-2407 | Length 7 mm | In distribution |
| 319-2424-SP-05 | Length 24 mm | In distribution |
| 210-3007-SP | In distribution | |
| 319-0740 | Length 40 mm | In distribution |
| 210-3011-SP | In distribution | |
| 316-0135 | In distribution | |
| 320-1616-SP-02 | In distribution | |
| 319-7045 | Length 52 mm | In distribution |
| 317-5580 | Length 80 mm | In distribution |
| 319-0020-SP-05 | Outer Diameter 2 mm | In distribution |
| 308-3026 | Length 26 mm | In distribution |
| 334-2016-SP-02 | Length 16 mm | In distribution |
| 211-1203-SP | Length 3 mm | In distribution |
| 331-2018 | Length 18 mm | In distribution |
| 317-2442 | Length 42 mm | In distribution |
| 319-7066 | Length 52 mm | In distribution |
| 317-2440-SP-05 | Length 40 mm | In distribution |
| 317-6596-SP-02 | Length 95 mm | In distribution |
| 317-5551 | Length 50 mm | In distribution |
| 331-1210-SP-05 | Length 10 mm | In distribution |
| 359-2408-SP-02 | Length 8 mm | In distribution |
| 317-5545-SP-02 | Length 44 mm | In distribution |
| 339-5544-SP-02 | Length 44 mm | In distribution |
| 316-1701 | Outer Diameter 2.8 mm | In distribution |
| 316-1702-SP-02 | Outer Diameter 2.8 mm | In distribution |
| 319-0805-SP-02 | Length 105 mm | In distribution |
| 316-0105-SP-02 | In distribution | |
| 331-1212 | Length 12 mm | In distribution |
| 318-3022 | Length 22 mm | In distribution |
| 319-7085-SP-02 | Length 52 mm | In distribution |
| 319-7115-SP | Length 52 mm | In distribution |
| 331-1610 | Length 10 mm | In distribution |
| 317-4555 | Length 55 mm | In distribution |
| 316-1609 | Outer Diameter 5.1 mm | In distribution |
| 306-2424-SP | Length 24 mm | In distribution |
| 334-2426 | Length 26 mm | In distribution |
| 316-1808 | In distribution | |
| 316-1606-SP-02 | Outer Diameter 4.7 mm | In distribution |
| 331-2036 | Length 36 mm | In distribution |
| 317-4560 | Length 60 mm | In distribution |
| 306-2410-SP-05 | Length 10 mm | In distribution |
| 315-4034 | Length 34 mm | In distribution |
| 308-1616 | Length 16 mm | In distribution |
| 319-0816-SP-02 | Length 115 mm | In distribution |
| 319-5542 | Length 42 mm | In distribution |
| 345-4590-SP-02 | Length 90 mm | In distribution |
| 315-2434 | Length 34 mm | In distribution |
| 308-3020-SP-05 | Length 20 mm | In distribution |
| 315-2411 | Length 11 mm | In distribution |
| 319-2406 | Length 6 mm | In distribution |
| 320-2925-11 | In distribution | |
| 320-2924-11 | In distribution | |
| 315-2016 | Length 16 mm | In distribution |
| 320-1624 | Outer Diameter 2.4 mm | In distribution |
| 306-2407-SP-05 | Length 7 mm | In distribution |
| 317-0751-SP-02 | Length 50 mm | In distribution |
| 330-1606 | Length 6 mm | In distribution |
| 345-6530 | Length 30 mm | In distribution |
| 319-4547 | Length 46 mm | In distribution |
| 318-2042 | Length 42 mm | In distribution |
| 318-2408 | Length 8 mm | In distribution |
| 317-3026-SP-05 | Length 26 mm | In distribution |
| 330-2430-SP-02 | Length 30 mm | In distribution |
| 318-2409 | Length 9 mm | In distribution |
| 319-6091-SP | Length 90 mm | In distribution |
| 317-6590 | Length 90 mm | In distribution |
| 319-6580 | Length 80 mm | In distribution |
| 317-0780-SP-02 | Length 80 mm | In distribution |
| 319-6571-SP-02 | Length 70 mm | In distribution |
| 316-0019 | In distribution | |
| 331-2034-SP-02 | Length 34 mm | In distribution |
| 358-2724 | Length 24 mm | In distribution |
| 317-3030 | Length 30 mm | In distribution |
| 319-6121 | Length 120 mm | In distribution |
| 316-1719 | In distribution | |
| 319-6120-SP-02 | Length 120 mm | In distribution |
| 334-2422-SP-02 | Length 22 mm | In distribution |
| 302-2012-SP-05 | Length 12 mm | In distribution |
| 317-5576-SP-02 | Length 75 mm | In distribution |
| 316-1804 | In distribution | |
| 331-1612 | Length 12 mm | In distribution |
| 320-1050-03 | In distribution | |
| 308-3016 | Length 16 mm | In distribution |
| 306-2436-SP-05 | Length 36 mm | In distribution |
| 317-4528 | Length 28 mm | In distribution |
| 331-2430 | Length 30 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
| Volt | Synthes Gmbh | 1,444 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202680 | 2020-10-15 |
| K163303 | 2017-04-04 |
| K151021 | 2015-07-15 |
| K140283 | 2014-02-28 |
| K130412 | 2013-05-31 |
| K023260 | 2002-10-18 |
| K010964 | 2001-07-05 |
| K010783 | 2001-05-30 |
| K974785 | 1998-03-18 |
| K954330 | 1995-12-08 |
| K932350 | 1995-07-05 |
| K924018 | 1993-04-01 |
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.