Inhance Intact
INHANCE INTACT HUMERAL REAMER X-LARGE Ø44mm
10manufacturers in China registered for this device type
11catalogue numbers in this listing
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 | Depuy (Ireland), Ireland |
|---|---|
| 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 | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-06-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6231-10-032 | In distribution | |
| 6231-10-040 | In distribution | |
| 6231-40-130 | In distribution | |
| 6231-31-008 | In distribution | |
| 6231-60-050 | In distribution | |
| 6231-60-030 | In distribution | |
| 6231-10-044 | In distribution | |
| 6231-10-036 | In distribution | |
| 6231-31-007 | In distribution | |
| 6231-60-020 | In distribution | |
| 6231-60-060 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stainless Steel Guide Wires | Orthopediatrics, Corp | 76 |
| OsteoMed | Osteomed | 36 |
| 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 |
Showing 12 of 64. All products under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
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.