OsteoMed
OsteoDriver2, Disposable Battery Powered Screwdriver, Sterile
10manufacturers in China registered for this device type
36catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (1), Guangdong (1). 3 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 7 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Suzhou Number WIN Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 16 |
Record
| Listed by | Osteomed, United States |
|---|---|
| FDA product code | KIJ |
| Device type | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-09-22 |
| Record revised | 2022-06-10 (version 4) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 1.4 to 3.66 in; outer diameter 1.6 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 450-0627 | In distribution | |
| 220-0323 | In distribution | |
| 450-1634 | Length 3.66 in | In distribution |
| 220-0390 | In distribution | |
| 450-0610 | In distribution | |
| 450-0629 | In distribution | |
| 220-0362 | In distribution | |
| 220-0423 | In distribution | |
| 220-0643-78 | In distribution | |
| 450-0601-SP | Length 1.4 in | In distribution |
| 450-0636 | In distribution | |
| 450-0625 | In distribution | |
| 220-0321 | In distribution | |
| 450-0614 | In distribution | |
| 451-0625 | In distribution | |
| 220-0640-152 | In distribution | |
| 220-0644-70 | In distribution | |
| 450-0628 | In distribution | |
| 450-0603 | In distribution | |
| 450-0620 | In distribution | |
| 450-0618 | In distribution | |
| 220-0324 | Outer Diameter 1.6 mm | In distribution |
| 450-0601 | In distribution | |
| 450-1616 | Length 1.88 in | In distribution |
| 450-0626 | In distribution | |
| 451-0603 | In distribution | |
| 450-1622 | Length 2.5 in | In distribution |
| 450-0630 | In distribution | |
| 450-0600 | In distribution | |
| 220-0322 | In distribution | |
| 220-0421 | In distribution | |
| 450-0619 | In distribution | |
| 220-0644-71 | In distribution | |
| 450-0602 | In distribution | |
| 450-0632 | In distribution | |
| 450-0700 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stainless Steel Guide Wires | Orthopediatrics, Corp | 76 |
| CS2 Acetabular System | Shalby Advanced Technologies, Inc. | 32 |
| Medinaut MAX | Imedicom Co., Ltd. | 25 |
| MicroAire® | Microaire Surgical Instruments LLC | 20 |
| R&D Batteries, Inc. | R & D Batteries, Inc. | 18 |
| Pediatric Nailing Platform | Tibia | Orthopediatrics, Corp | 17 |
| PNP Tibia | Orthopediatrics, Corp | 14 |
| EZImpactor | Imedicom Co., Ltd. | 13 |
| Insurgical, Inc. | Insurgical, Inc. | 12 |
| Response Spine System | Orthopediatrics, Corp | 12 |
| 3P Hip System | Orthopediatrics, Corp | 12 |
| Global Steptech | Depuy (Ireland) | 12 |
Showing 12 of 64. All products under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K933101 | 1994-11-07 |
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.