Instrument
3-6 Revision Tibial Prep AND Trials Lower Tray Triathlon Revision Instruments
105manufacturers in China registered for this device type
230catalogue numbers in this listing
1recall
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 | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | FSM |
| Device type | Tray, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2022-11-11 (version 9) |
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, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0590-2-200 | In distribution | |
| 6543-6-522 | In distribution | |
| 6543-6-512 | In distribution | |
| 1235-0-305 | In distribution | |
| 6543-6-551 | In distribution | |
| 1440-2091 | In distribution | |
| 6541-8-105E | In distribution | |
| 6541-8-130 | In distribution | |
| 7000-0100 | In distribution | |
| 6278-9-801 | In distribution | |
| 6541-9-202 | In distribution | |
| 6278-9-803 | In distribution | |
| 6543-6-521 | In distribution | |
| 6278-9-706 | In distribution | |
| 6543-8-102 | In distribution | |
| 6541-8-008 | In distribution | |
| 6147-2-101 | In distribution | |
| 6543-8-114 | In distribution | |
| 6278-9-802 | In distribution | |
| 4845-7-603 | In distribution | |
| 6543-6-524 | In distribution | |
| 6543-6-515 | In distribution | |
| 6543-6-514 | In distribution | |
| 6541-9-100 | In distribution | |
| 6543-8-118 | In distribution | |
| 5900-8114 | In distribution | |
| 6556-9-111 | In distribution | |
| 1235-0-302 | In distribution | |
| 1030-4000 | In distribution | |
| 0585-9-901 | In distribution | |
| 6278-9-806 | In distribution | |
| 6541-9-014 | In distribution | |
| 6541-8-108 | In distribution | |
| 6543-6-505 | In distribution | |
| 6541-9-109 | In distribution | |
| 2107-4005 | In distribution | |
| 6543-6-552 | In distribution | |
| 6543-6-509 | In distribution | |
| 2402-0007 | In distribution | |
| 6278-9-700 | In distribution | |
| 6541-9-110 | In distribution | |
| 1440-0030 | In distribution | |
| 6541-9-113 | In distribution | |
| 6543-8-115 | In distribution | |
| 6543-6-554 | In distribution | |
| 6541-9-102 | In distribution | |
| 6543-6-526 | In distribution | |
| 6541-8-004E | In distribution | |
| 6543-6-501 | In distribution | |
| 6543-6-511 | In distribution | |
| 1440-0001 | In distribution | |
| 6541-8-002 | In distribution | |
| 1020-6000 | In distribution | |
| 6541-8-113 | In distribution | |
| 6278-9-703 | In distribution | |
| 6543-6-519 | In distribution | |
| 7000-5520 | In distribution | |
| 6543-6-508 | In distribution | |
| 5555-5111 | In distribution | |
| I-K4223RT11 | In distribution | |
| 0585-9-902 | In distribution | |
| 6147-1-102 | In distribution | |
| 6543-6-553 | In distribution | |
| 6278-9-807, Rev AC | In distribution | |
| 6541-9-410 | In distribution | |
| 0943-9-001 | In distribution | |
| 6541-9-010 | In distribution | |
| 5555-5112 | In distribution | |
| 6147-1-101 | In distribution | |
| 6541-9-207-R | Side: RIGHT | In distribution |
| 6278-9-808, Rev AC | In distribution | |
| 6543-8-005 | In distribution | |
| 6541-9-205-L | Side: LEFT | In distribution |
| 7000-0103 | In distribution | |
| 6278-9-708 | In distribution | |
| 6278-9-805 | In distribution | |
| 6543-6-510 | In distribution | |
| 1100-1404 | In distribution | |
| 6543-8-002 | In distribution | |
| 6541-9-000 | In distribution | |
| 6278-9-702 | In distribution | |
| 6543-6-525 | In distribution | |
| 8000-0100 | In distribution | |
| 1601-5005 | In distribution | |
| 6541-9-105 | In distribution | |
| 6543-8-015 | In distribution | |
| 6541-9-107 | In distribution | |
| 6543-6-502 | In distribution | |
| 7000-0102 | In distribution | |
| 0585-9-903 | In distribution | |
| 1235-0-303A | In distribution | |
| 6541-9-103 | In distribution | |
| 6278-9-705 | In distribution | |
| 0585-9-904 | In distribution | |
| 4845-7-600 | In distribution | |
| 6543-6-520 | In distribution | |
| 1440-0002 | In distribution | |
| 6543-8-011 | In distribution | |
| 6541-8-105 | In distribution | |
| 1020-9101 | In distribution | |
| 6147-3-104 | In distribution | |
| 6543-6-504 | In distribution | |
| 6556-9-222 | In distribution | |
| 6543-8-103 | In distribution | |
| 0585-9-905 | In distribution | |
| 6147-3-106 | In distribution | |
| 5650-8-002 | In distribution | |
| 1100-1400 | In distribution | |
| 6278-9-701 | In distribution | |
| 6543-6-507 | In distribution | |
| 0943-9-000 | In distribution | |
| 6541-8-122 | In distribution | |
| 6541-9-112 | In distribution | |
| 6543-8-101 | In distribution | |
| 7000-5522 | In distribution | |
| 6541-8-009 | In distribution | |
| 7000-0104 | In distribution | |
| 4845-7-602 | In distribution | |
| 6543-8-104 | In distribution | |
| 6543-6-513 | In distribution | |
| 6543-6-518 | In distribution | |
| 6147-3-110 | In distribution | |
| 6543-8-001 | In distribution | |
| 6541-0-936 | In distribution | |
| 6543-8-105 | In distribution | |
| 1601-5007 | In distribution | |
| 1235-0-306 | In distribution | |
| 6278-9-804 | In distribution | |
| 1020-9003 | In distribution | |
| 1100-1403 | In distribution | |
| 6541-8-104 | In distribution | |
| 1100-1405 | In distribution | |
| 1440-2092 | In distribution | |
| 6541-8-021 | In distribution | |
| 6541-8-005 | In distribution | |
| 1601-5006 | In distribution | |
| 6543-6-960 | In distribution | |
| 6543-8-003 | In distribution | |
| 0590-1-500 | In distribution | |
| 5555-5110 | In distribution | |
| 7000-5524 | In distribution | |
| 5650-8-001 | In distribution | |
| 6541-8-100 | In distribution | |
| 4845-7-601 | In distribution | |
| 2400-0300 | In distribution | |
| 1235-0-300 | In distribution | |
| 6541-8-112 | In distribution | |
| 6541-9-115 | In distribution | |
| 6147-3-103 | In distribution | |
| 6541-9-116 | In distribution | |
| 6541-9-114 | In distribution | |
| 6541-8-004 | In distribution | |
| 6541-9-101 | In distribution | |
| 2400-0100 | In distribution | |
| 6543-8-013 | In distribution | |
| 6541-8-002E | In distribution | |
| 6147-3-105 | In distribution | |
| 6543-8-007 | In distribution | |
| 1235-0-305A | In distribution | |
| 0943-9-002 | In distribution | |
| 1235-0-301 | In distribution | |
| 6147-3-108 | In distribution | |
| 6543-8-014 | In distribution | |
| 1020-8500 | In distribution | |
| 0590-1-202 | In distribution | |
| 6543-8-004 | In distribution | |
| 6541-9-118 | In distribution | |
| 6543-8-009 | In distribution | |
| 1020-9102 | In distribution | |
| 2402-0009 | In distribution | |
| 1020-9001 | In distribution | |
| 2402-0010 | In distribution | |
| 6543-6-503 | In distribution | |
| 6541-9-117 | In distribution | |
| 1020-9000 | In distribution | |
| 6541-9-006 | In distribution | |
| I-K4223RT12 | In distribution | |
| 6541-9-205-R | Side: RIGHT | In distribution |
| 6541-8-005E | In distribution | |
| 6278-9-707 | In distribution | |
| 6541-8-140 | In distribution | |
| 1020-9002 | In distribution | |
| 6541-8-040 | In distribution | |
| 6541-8-030 | In distribution | |
| 6541-9-104 | In distribution | |
| 6541-8-022 | In distribution | |
| 7000-5523 | In distribution | |
| 6278-9-800 | In distribution | |
| 6543-6-516 | In distribution | |
| 6543-6-517 | In distribution | |
| 5097-1000 | In distribution | |
| 6543-6-556 | In distribution | |
| 6543-8-018 | In distribution | |
| 6541-9-201 | In distribution | |
| 6543-8-017 | In distribution | |
| 2402-0011 | In distribution | |
| 2400-0200 | In distribution | |
| 6147-3-107 | In distribution | |
| 4845-9-000 | In distribution | |
| 6147-3-102 | In distribution | |
| 1100-1402 | In distribution | |
| 7000-0101 | In distribution | |
| 1440-2093 | In distribution | |
| 6541-9-206 | In distribution | |
| 4200-105-0 | In distribution | |
| 6147-0-100 | In distribution | |
| 6541-9-200 | In distribution | |
| 6543-6-513X | In distribution | |
| 5650-8-101 | In distribution | |
| 6541-9-106 | In distribution | |
| 7000-5521 | In distribution | |
| 6543-6-506 | In distribution | |
| 6541-8-102 | In distribution | |
| 5555-5113 | In distribution | |
| 6541-8-109 | In distribution | |
| 1440-0040 | In distribution | |
| 6147-3-101 | In distribution | |
| 6541-9-207-L | Side: LEFT | In distribution |
| 6543-8-109 | In distribution | |
| 6541-8-120 | In distribution | |
| 6060-9-090 | In distribution | |
| 6543-8-016 | In distribution | |
| 1020-7000 | In distribution | |
| 6543-8-117 | In distribution | |
| 6278-9-704 | In distribution | |
| 2107-4006 | In distribution | |
| 6543-6-555 | In distribution | |
| 4845-9-100 | In distribution | |
| 6543-6-523 | In distribution | |
| 0585-9-900 | In distribution |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | UDI-DI | 2021-11-24 | Class II | Under Investigation by firm | Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if | 7 units |
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.