Monarch
MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 4.75mm
105manufacturers in China registered for this device type
50catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument
Record
| Listed by | Depuy Spine, Inc., United States |
|---|---|
| FDA product code | FSM |
| Device type | Tray, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-12-31 |
| Record revised | 2022-09-16 (version 10) |
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 | 2019-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 277495500 | In distribution | |
| 277498000 | Withdrawn | |
| 277093475 | Withdrawn | |
| 277094625 | Withdrawn | |
| 277094550 | Withdrawn | |
| 277090000 | Withdrawn | |
| 277091110 | Withdrawn | |
| 277090400 | Withdrawn | |
| 277493775 | Withdrawn | |
| 277092550 | Withdrawn | |
| 277092475 | Withdrawn | |
| 277095400 | Withdrawn | |
| 277495000 | Withdrawn | |
| 277095500 | Withdrawn | |
| 277493625 | Withdrawn | |
| 277093850 | Withdrawn | |
| 277490400 | Withdrawn | |
| 277091100 | Withdrawn | |
| 277495100 | Withdrawn | |
| 277493850 | Withdrawn | |
| 277093550 | Withdrawn | |
| 277491200 | Withdrawn | |
| 277091000 | Withdrawn | |
| 277094700 | Withdrawn | |
| 277091775 | Withdrawn | |
| 277090500 | Withdrawn | |
| 277490000 | Withdrawn | |
| 277093700 | Withdrawn | |
| 277092850 | Withdrawn | |
| 277493475 | Withdrawn | |
| 277091210 | Withdrawn | |
| 277098000 | Withdrawn | |
| 277493000 | Withdrawn | |
| 277493550 | Withdrawn | |
| 277093100 | Withdrawn | |
| 277090300 | Withdrawn | |
| 277091850 | Withdrawn | |
| 277093625 | Withdrawn | |
| 277094475 | Withdrawn | |
| 277091205 | Withdrawn | |
| 277095000 | Withdrawn | |
| 277097785 | Withdrawn | |
| 277490500 | Withdrawn | |
| 277092700 | Withdrawn | |
| 277493700 | Withdrawn | |
| 277092775 | Withdrawn | |
| 277091550 | Withdrawn | |
| 277091475 | Withdrawn | |
| 277092625 | Withdrawn | |
| 277093775 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IMS | HU-Friedy MFG Co., LLC | 2,710 |
| Tray, Surgical, Instrument | Synthes Gmbh | 1,052 |
| Tray, Surgical, Instrument | Medtronic Sofamor Danek, Inc. | 1,012 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 666 |
| Aptus | Medartis Inc. | 588 |
| Acumed | Acumed LLC | 566 |
| Aesculap | Aesculap AG | 532 |
| Sklar | Sklar Corporation | 465 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 438 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 429 |
| Level ONE | KLS-Martin L.P. | 341 |
| Bahadir USA | Bahadir USA LLC | 300 |
Showing 12 of 3,212. All products under Tray, Surgical, Instrument
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.