Mini
3.0mm Depth Gauge/ Countersink
31manufacturers in China registered for this device type
122catalogue numbers in this listing
6510(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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K120493 |
| Record published | 2017-03-30 |
| Record revised | 2025-04-14 (version 11) |
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 10 to 50 mm |
| Distribution end date | 2021-10-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IH3034 | Diameter: 3.0 Millimeter | In distribution |
| IC3034 | Length 34.0 mm | In distribution |
| IH2510 | Length 10.0 mm | In distribution |
| IC4020 | Diameter: 4.0 Millimeter | In distribution |
| IC3026 | Length 26.0 mm | In distribution |
| IH3020 | Length 20.0 mm | In distribution |
| IC3018 | Diameter: 3.0 Millimeter | In distribution |
| IC4034 | Length 34.0 mm | In distribution |
| IC2524 | Diameter: 2.5 Millimeter | In distribution |
| IS1110 | In distribution | |
| IH4022 | Diameter: 4.0 Millimeter | In distribution |
| IC2526 | Length 26.0 mm | In distribution |
| KN1115 | Diameter: 0.9 Millimeter | In distribution |
| IC3014 | Length 14.0 mm | In distribution |
| IC4036 | Length 36.0 mm | In distribution |
| IC3022 | Length 22.0 mm | In distribution |
| IH3026 | Diameter: 3.0 Millimeter | In distribution |
| IS1114 | Diameter: 2.6 Millimeter | In distribution |
| IH4032 | Diameter: 4.0 Millimeter | In distribution |
| IC3032 | Diameter: 3.0 Millimeter | In distribution |
| KN1117 | Diameter: 1.2 Millimeter | In distribution |
| IC3028 | Length 28.0 mm | In distribution |
| IH4048 | Diameter: 4.0 Millimeter | In distribution |
| IC3036 | Diameter: 3.0 Millimeter | In distribution |
| IH2530 | Length 30.0 mm | In distribution |
| IH4018 | Diameter: 4.0 Millimeter | In distribution |
| IC2520 | Diameter: 2.5 Millimeter | In distribution |
| IH3024 | Diameter: 3.0 Millimeter | In distribution |
| IC2512 | Diameter: 2.5 Millimeter | In distribution |
| IH2528 | Length 28.0 mm | In distribution |
| IH4034 | Diameter: 4.0 Millimeter | In distribution |
| IC3012 | Length 12.0 mm | In distribution |
| IC2510 | Length 10.0 mm | In distribution |
| IS1108 | In distribution | |
| IH4020 | Diameter: 4.0 Millimeter | In distribution |
| IH3040 | Length 40.0 mm | In distribution |
| IH2512 | Length 12.0 mm | In distribution |
| IC2514 | Diameter: 2.5 Millimeter | In distribution |
| IS1102 | In distribution | |
| IC2540 | Diameter: 2.5 Millimeter | In distribution |
| IH4042 | Diameter: 4.0 Millimeter | In distribution |
| IS1104 | In distribution | |
| IS1107 | In distribution | |
| IC2516 | Diameter: 2.5 Millimeter | In distribution |
| IS1101 | In distribution | |
| IH2532 | Diameter: 2.5 Millimeter | In distribution |
| IC4018 | Diameter: 4.0 Millimeter | In distribution |
| IH4012 | Diameter: 4.0 Millimeter | In distribution |
| IC3016 | Length 16.0 mm | In distribution |
| IC4048 | Diameter: 4.0 Millimeter | In distribution |
| IC2528 | Length 28.0 mm | In distribution |
| IC3030 | Diameter: 3.0 Millimeter | In distribution |
| IH3032 | Diameter: 3.0 Millimeter | In distribution |
| IH2520 | Length 20.0 mm | In distribution |
| IC4014 | Length 14.0 mm | In distribution |
| IS1111 | In distribution | |
| IS1106 | In distribution | |
| IH3014 | Length 14.0 mm | In distribution |
| IS1113 | Diameter: 2.1 Millimeter | In distribution |
| IH2514 | Diameter: 2.5 Millimeter | In distribution |
| IS1112 | Diameter: 1.9 Millimeter | In distribution |
| IC4032 | Length 32.0 mm | In distribution |
| IH4036 | Diameter: 4.0 Millimeter | In distribution |
| IH2522 | Diameter: 2.5 Millimeter | In distribution |
| IH3018 | Length 18.0 mm | In distribution |
| IH4024 | Diameter: 4.0 Millimeter | In distribution |
| IH2540 | Diameter: 2.5 Millimeter | In distribution |
| IH2538 | Length 40.0 mm | In distribution |
| IH4050 | Diameter: 4.0 Millimeter | In distribution |
| IC3024 | Length 24.0 mm | In distribution |
| IS1105 | In distribution | |
| IH2516 | Length 16.0 mm | In distribution |
| IS1109 | In distribution | |
| IC4044 | Length 44.0 mm | In distribution |
| IH4044 | Diameter: 4.0 Millimeter | In distribution |
| IC2518 | Diameter: 2.5 Millimeter | In distribution |
| IH2534 | Length 34.0 mm | In distribution |
| IC4016 | Length 16.0 mm | In distribution |
| IH4040 | Diameter: 4.0 Millimeter | In distribution |
| IH3016 | Diameter: 3.0 Millimeter | In distribution |
| IH4014 | Length 14.0 mm | In distribution |
| IC3040 | Length 40.0 mm | In distribution |
| IH4026 | Length 26.0 mm | In distribution |
| IC4022 | Length 22.0 mm | In distribution |
| IC2530 | Length 30.0 mm | In distribution |
| IH2518 | Diameter: 2.5 Millimeter | In distribution |
| IC4012 | Diameter: 4.0 Millimeter | In distribution |
| IC4040 | Diameter: 4.0 Millimeter | In distribution |
| IC2534 | Length 34.0 mm | In distribution |
| IH4030 | Length 30.0 mm | In distribution |
| IH3030 | Length 30.0 mm | In distribution |
| IH4038 | Diameter: 4.0 Millimeter | In distribution |
| IC4028 | Length 28.0 mm | In distribution |
| IC3020 | Length 20.0 mm | In distribution |
| IS1103 | In distribution | |
| IC2538 | Diameter: 2.5 Millimeter | In distribution |
| IC4046 | Diameter: 4.0 Millimeter | In distribution |
| IH3036 | Diameter: 3.0 Millimeter | In distribution |
| IH3022 | Length 22.0 mm | In distribution |
| IH2536 | Length 36.0 mm | In distribution |
| IH2524 | Diameter: 2.5 Millimeter | In distribution |
| IH3012 | Length 12.0 mm | In distribution |
| IC4030 | Diameter: 4.0 Millimeter | In distribution |
| IC4026 | Length 26.0 mm | In distribution |
| IH4016 | Diameter: 4.0 Millimeter | In distribution |
| IC2522 | Diameter: 2.5 Millimeter | In distribution |
| IH3028 | Length 28.0 mm | In distribution |
| IH3010 | Diameter: 3.0 Millimeter | In distribution |
| IC2532 | Diameter: 2.5 Millimeter | In distribution |
| IH4046 | Length 46.0 mm | In distribution |
| IC4050 | Length 50.0 mm | In distribution |
| IC4024 | Diameter: 4.0 Millimeter | In distribution |
| IC3010 | Diameter: 3.0 Millimeter | In distribution |
| IC2536 | Length 36.0 mm | In distribution |
| IH2526 | Length 26.0 mm | In distribution |
| IC4042 | Diameter: 4.0 Millimeter | In distribution |
| KN1116 | Diameter: 1.15 Millimeter | In distribution |
| IH3038 | Diameter: 3.0 Millimeter | In distribution |
| IC4038 | Diameter: 4.0 Millimeter | In distribution |
| IH4028 | Length 28.0 mm | In distribution |
| IC3038 | Diameter: 3.0 Millimeter | In distribution |
| IS1100 | Withdrawn |
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 |
| OsteoMed | Osteomed | 2,764 |
| 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 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220319 | 2022-06-10 |
| K213199 | 2022-01-11 |
| K193366 | 2020-03-20 |
| K183104 | 2019-06-10 |
| K180500 | 2018-06-04 |
| K173135 | 2017-11-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Instratek, Inc. | 510(k) number | 2013-04-25 | Class II | Nonconforming Material/Component | Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set. | 96 | 2016-01-26 |
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.