Rongeur
Bone, Leksell, Stille, Flat TIP, 8 MM Jaws
11manufacturers in China registered for this device type
86catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (5), Shandong (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Qingdao Zhixing Medical Instrument Co., Ltd. | Qingdao | Shandong | Manufacturer | 6 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | HTX |
| Device type | Rongeur |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2025-04-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-12-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 23-807-17-07 | 16.5 CM | In distribution |
| 23-835-30-07 | 14.5 CM | In distribution |
| 23-909-24-07 | 24 CM | In distribution |
| 23-780-04-07 | 15 CM | In distribution |
| 96-300-41-07 | 17 CM | In distribution |
| 23-887-18-07 | 18.5 CM | In distribution |
| 23-911-22-07 | 22 CM | In distribution |
| 23-853-15-07 | 15 CM | In distribution |
| 23-899-04-07 | 23 CM | In distribution |
| 23-910-22-07 | 22 CM | In distribution |
| 23-819-18-07 | 18 CM | In distribution |
| 23-893-23-07 | 23 CM | In distribution |
| 23-777-01-07 | 17 CM | In distribution |
| 23-780-01-07 | 16 CM | In distribution |
| 23-805-14-07 | 13 CM | In distribution |
| 23-957-27-07 | 27 CM | In distribution |
| 23-801-14-07 | 14 CM | In distribution |
| 23-827-18-07 | 18 CM | In distribution |
| 99-561-20-01 | 24 CM | In distribution |
| 23-865-15-07 | 15 CM | In distribution |
| 23-832-19-07 | 19 CM | In distribution |
| 99-584-23-01 | 24 CM | In distribution |
| 23-803-14-07 | 14 CM | In distribution |
| 23-839-15-07 | 15 CM | In distribution |
| 23-777-02-07 | 16.5 CM | In distribution |
| 23-897-23-07 | 23 CM | In distribution |
| 23-836-30-07 | 15.5 CM | In distribution |
| 01-051-21-07 | In distribution | |
| 23-829-18-07 | 18 CM | In distribution |
| 23-780-02-07 | 15 CM | In distribution |
| 23-835-15-07 | 15 CM | In distribution |
| 23-815-16-07 | 16.5 CM | In distribution |
| 23-905-24-07 | 25 CM | In distribution |
| 09-879-18-07 | 19 CM | In distribution |
| 23-876-15-07 | 15 CM | In distribution |
| 23-877-15-07 | 15 CM | In distribution |
| 23-899-03-07 | 23 CM | In distribution |
| 23-901-23-07 | 23 CM | In distribution |
| 23-811-13-07 | 13 CM | In distribution |
| 23-899-02-07 | 23 CM | In distribution |
| 23-826-18-07 | 18 CM | In distribution |
| 23-799-12-07 | 12 CM | In distribution |
| 23-879-18-07 | 18 CM | In distribution |
| 23-864-15-07 | 15 CM | In distribution |
| 23-847-17-07 | 18 CM | In distribution |
| 23-846-17-07 | 18 CM | In distribution |
| 23-780-03-07 | 15 CM | In distribution |
| 23-807-16-07 | 17 CM | In distribution |
| 23-837-15-07 | 15 CM | In distribution |
| 23-881-18-07 | 18 CM | In distribution |
| 23-799-14-07 | 14 CM | In distribution |
| 23-907-24-07 | 24 CM | In distribution |
| 24-986-03-07 | Withdrawn | |
| 24-994-03-07 | 18 CM | Withdrawn |
| 24-994-06-07 | 18 CM | Withdrawn |
| 24-996-03-07 | 18 CM | Withdrawn |
| 24-995-08-07 | Withdrawn | |
| 24-995-09-07 | Withdrawn | |
| 24-994-05-07 | 15 CM | Withdrawn |
| 24-995-01-07 | Withdrawn | |
| 01-010-23-07 | Withdrawn | |
| 24-996-09-07 | 18 CM | Withdrawn |
| 24-996-06-07 | 18 CM | Withdrawn |
| 24-996-05-07 | 15 CM | Withdrawn |
| 24-995-05-07 | Withdrawn | |
| 24-992-01-07 | Withdrawn | |
| 24-994-04-07 | 12 CM | Withdrawn |
| 24-996-02-07 | 15 CM | Withdrawn |
| 04-993-02-07 | Withdrawn | |
| 23-942-17-07 | 17 CM | Withdrawn |
| 24-996-07-07 | 12 CM | Withdrawn |
| 04-991-02-07 | Withdrawn | |
| 04-005-16-07 | Withdrawn | |
| 24-996-08-07 | 15 CM | Withdrawn |
| 24-995-03-07 | Withdrawn | |
| 24-983-03-07 | Withdrawn | |
| 24-996-01-07 | 12 CM | Withdrawn |
| 24-995-07-07 | Withdrawn | |
| 96-233-38-07 | 15 CM | Withdrawn |
| 24-994-08-07 | 15 CM | Withdrawn |
| 04-005-17-07 | Withdrawn | |
| 24-996-04-07 | 12 CM | Withdrawn |
| 09-835-15-07 | 15 CM | Withdrawn |
| 24-995-04-07 | Withdrawn | |
| 24-993-06-07 | Withdrawn | |
| 24-995-06-07 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 2,994 |
| Life Instruments | Life Instrument Corp. | 1,252 |
| Novo Surgical | Novo Surgical, Inc. | 1,227 |
| Surgical Direct | Surgical Direct, Inc. | 1,208 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 712 |
| gSource | Gsource, LLC. | 509 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 397 |
| Peak MED | Peak Medical Distribution Inc | 320 |
| Aesculap | Aesculap AG | 264 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 244 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 239 |
| HNM Medical | HNM Stainless, LLC. | 186 |
Showing 12 of 438. All products under Rongeur
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.