Spinal System
14 catalogue numbers from 130M2104, listed by Biomet Spine, United States, under Rongeur. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
14catalogue 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 | Biomet Spine, United States |
|---|---|
| FDA product code | HTX |
| Device type | Rongeur |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2018-07-13 |
| Record revised | 2025-01-03 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130M2104 | Kerrison Rongeur 90° 4 mm | In distribution |
| 130M2003 | Kerrison Rongeur 40° 3 mm | In distribution |
| 130M1012 | Micro Pituitary Rongeur Straight 2 mm | In distribution |
| 130M2002 | Kerrison Rongeur 40° 2 mm | In distribution |
| 130M1112 | Micro Pituitary Rongeur 2 mm Up | In distribution |
| 130M3003 | Kerrison Rongeur 40° Curved 3 mm | In distribution |
| 130M2103 | Kerrison Rongeur 90° 3 mm | In distribution |
| 130M3002 | Kerrison Rongeur 40° Curved 2 mm | In distribution |
| 130M1002 | Pituitary Rongeur Straight 2 mm | In distribution |
| 130M1004 | Pituitary Rongeur Straight 4 mm | In distribution |
| 130M1102 | Pituitary Rongeur Up 2 mm | In distribution |
| 130M1104 | Pituitary Rongeur Up 4 mm | In distribution |
| 130M1025 | Pituitary Rongeur Straight 6 mm | In distribution |
| 130M2004 | Kerrison Rongeur 40° 4 mm | In distribution |
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.