Knife, Orthopedic
Knives (1) Hook Blade (1) Triangle Blade Endotrac Blade System
7manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Bandex Industrial Corp. | Zhuhai | Guangdong | Contract manufacturer | 14 |
| Zhangjiagang Alldex Commodity Co., Ltd. | Zhangjiagang | Jiangsu | Private-label distributor | 5 |
Record
| Listed by | Sterilmed, Inc., United States |
|---|---|
| FDA product code | HTS |
| Device type | Knife, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-08-13 |
| Record revised | 2025-07-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-06-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DYO4116 | 3 | Withdrawn | |
| LIN70-0071-113 | Withdrawn | ||
| ACU010620 | Withdrawn | ||
| ACU010630 | Withdrawn | ||
| ACU010660 | Withdrawn | ||
| LIN70-0071-103 | Withdrawn | ||
| ACU010600 | Withdrawn | ||
| INS4058A | Withdrawn | ||
| INS3056 | 2 | Withdrawn | |
| WHIOR1201 | Withdrawn | ||
| RIC130716 | Withdrawn | ||
| ACU010650 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| gSource | Gsource, LLC. | 61 |
| Medline | Medline Industries, Inc. | 21 |
| Best | Lacey Manufacturing Company LLC | 18 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 15 |
| Arthroscopic Meniscotome | Sontec Instruments, Inc. | 10 |
| Ambler Surgical | Ambler Surgical, LLC | 8 |
| Kmedic | Teleflex Medical LLC | 7 |
| Nasal/Tendon Knife | Sontec Instruments, Inc. | 6 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 6 |
| Infinity™ | ConMed Corporation | 6 |
| Millennium | Avalign Technologies, Inc. | 5 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 5 |
Showing 12 of 87. All products under Knife, Orthopedic
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.