Step Boss
Step OSStaple 20 x 20 x 9 W2x3
7manufacturers in China registered for this device type
27catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). 5 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 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Biomedical Enterprises, Inc., United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Record published | 2015-10-24 |
| Record revised | 2021-11-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 2 to 35 mm; width 15 to 25 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS-1520-02W2 | Width 15 mm | In distribution |
| 451-0215 | Width 15 mm | In distribution |
| 461-0520 | Length 04 mm | In distribution |
| 461-0420 | Width 20 mm | In distribution |
| 441-0115 | Length 02 mm | In distribution |
| OS-2020-09W2x3 | Width 20 mm | In distribution |
| OS-2020-02W2x3 | Length 02 mm | In distribution |
| 451-0515 | Length 12 mm | In distribution |
| 461-0325 | Width 25 mm | In distribution |
| OS-1520-12W2 | Width 15 mm | In distribution |
| OS-1520-04W2 | Length 04 mm | In distribution |
| 461-0620 | Length 06 mm | In distribution |
| 451-0415 | Width 15 mm | In distribution |
| 461-0720 | Width 20 mm | In distribution |
| 451-0115 | Length 06 mm | In distribution |
| OS-2020-06W2x3 | Length 06 mm | In distribution |
| 461-0220 | Length 09 mm | In distribution |
| OS-2020-04W2x3 | Width 20 mm | In distribution |
| 461-0320 | Length 12 mm | In distribution |
| OS-2020-12W2x3 | Length 12 mm | In distribution |
| 451-0315 | Length 02 mm | In distribution |
| OS-1520-06W2 | Width 15 mm | In distribution |
| OS-1520-09W2 | Length 09 mm | In distribution |
| 441-0215 | Width 15 mm | In distribution |
| 461-0125 | Length 09 mm | In distribution |
| 461-0120 | Width 20 mm | In distribution |
| 461-0820 | Width 20 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DynaBridge | Fusion Orthopedics, LLC | 156 |
| Arthrex® | Arthrex, Inc. | 80 |
| Staple, Fixation, Bone | Smith & Nephew, Inc. | 59 |
| Compression Staple System | Tornier Inc. | 36 |
| UNI-Clip | Newdeal Sas | 35 |
| Z-Staple | Z-Medical Gmbh & Co. KG | 34 |
| Orbitum Staple System | CPM Medical Consultants, LLC. | 32 |
| OSStaple | Biomedical Enterprises, Inc. | 30 |
| Acumed | Acumed LLC | 30 |
| Stealthfix Intraosseous Fixation System | Medartis Inc. | 29 |
| Staple, Fixation, Bone | Stryker GmbH | 29 |
| Fuseforce | Wright Medical Technology, Inc. | 26 |
Showing 12 of 319. All products under Staple, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150125 | 2015-05-11 |
| K142292 | 2014-11-17 |
| K133270 | 2014-04-17 |
| K124022 | 2013-05-14 |
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.