Romeo 2 Instrumentation
CANNULATED TAP Ø 4.5 x 30. NAV.
12manufacturers in China registered for this device type
22catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Spineart SA, Switzerland |
|---|---|
| FDA product code | HWX |
| Device type | Tap, Bone |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-19 |
| Record revised | 2022-12-08 (version 2) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MIS-IN 47 07-N | In distribution | |
| NAV-IN 47 05-N | In distribution | |
| SPE-IN 01 36-N | In distribution | |
| ELL-IN 65 30-N | In distribution | |
| ELL-IN 70 30-N | In distribution | |
| ELL-IN 75 30-N | In distribution | |
| ELL-IN 50 30-N | In distribution | |
| ELL-IN 55 30-N | In distribution | |
| ELL-IN 45 30-N | In distribution | |
| ELL-IN 60 30-N | In distribution | |
| SPE-IN 00 67-N | In distribution | |
| NAV-IN 47 06-N | In distribution | |
| SPE-IN 00 95-N | In distribution | |
| NAV-IN 47 07-N | In distribution | |
| MIS-IN 47 06-N | In distribution | |
| MIS-IN 47 05-N | In distribution | |
| SPE-IN 01 35-N | In distribution | |
| SPE-IN 00 66-N | In distribution | |
| NAV-IN 40 30-N | In distribution | |
| SPE-IN 01 38-N | In distribution | |
| ELL-IN 40 30-N | In distribution | |
| SPE-IN 01 37-N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 429 |
| Mariner | Seaspine Orthopedics Corporation | 285 |
| Tap, Bone | Depuy Spine, Inc. | 248 |
| Tap, Bone | Medtronic Sofamor Danek, Inc. | 228 |
| Tap, Bone | Synthes Gmbh | 191 |
| Invictus | Alphatec Spine, Inc. | 129 |
| Specials | Seaspine Orthopedics Corporation | 99 |
| Arsenal | Alphatec Spine, Inc. | 82 |
| Generic Surgical Instruments | CTL Medical Corporation | 81 |
| Mariner MIS | Seaspine Orthopedics Corporation | 78 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 72 |
| Custom | Medicrea International | 68 |
Showing 12 of 545. All products under Tap, Bone
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.