Tray, Surgical, Instrument
224 catalogue numbers from 1179-70, listed by Zimmer, Inc., United States, under Tray, Surgical, Instrument. 105 manufacturers in China are registered for this product code.
105manufacturers in China registered for this device type
224catalogue numbers in this listing
3recalls on this code
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 | Zimmer, Inc., United States |
|---|---|
| FDA product code | FSM |
| Device type | Tray, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-05-09 |
| 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, expiry date, manufacturing date |
| Sizes | Depth 38.1 to 152.4 mm |
| Distribution end date | 2017-12-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1179-70 | In distribution | |
| 4903-30 | In distribution | |
| 5888-15-35 | Depth 88.9 mm | In distribution |
| 5888-15-15 | Depth 38.1 mm | In distribution |
| 00-2300-040-00 | 2.0, 2.7, 3.5 mm Plates Base and Tray | In distribution |
| 5888-00-60 | Depth 152.4 mm | In distribution |
| 00-2366-075-00 | In distribution | |
| 5941-65 | In distribution | |
| 7805-95 | In distribution | |
| 6890-99-910 | In distribution | |
| 7806-99-30 | 12/14 C-Ring Taper Slotted, 40 mm Diameter | In distribution |
| 9275-00-150 | In distribution | |
| 00-2366-075-30 | In distribution | |
| 00-7712-075-00 | 0 mm Rasp Case, Size 4 – 22.5 | In distribution |
| 9366-99-161 | In distribution | |
| 00-5752-025-00 | In distribution | |
| 9368-99-180 | 32 mm Standard and, Hooded Insert Trial Case | In distribution |
| 6890-99-941 | Size 5 | In distribution |
| 5888-12-60 | Depth 152.4 mm | In distribution |
| 5841-50 | In distribution | |
| 5888-15-30 | Depth 76.2 mm | In distribution |
| 00-5752-045-00 | In distribution | |
| 5789-92 | In distribution | |
| 1179-65 | In distribution | |
| 7890-99-000 | In distribution | |
| 8000-99-000 | In distribution | |
| 5225-80 | Size 54 mm and 74 mm Case Set | In distribution |
| 6890-99-821 | In distribution | |
| 00-5853-058-00 | 3/4 mm Reamer Case, 8.75 mm – 18.75 mm Diameter | In distribution |
| 6275-18 | In distribution | |
| 7805-70 | In distribution | |
| 00-7805-070-50 | In distribution | |
| 5888-00-50 | Depth 127 mm | In distribution |
| 00-5752-010-00 | In distribution | |
| 6890-99-801 | In distribution | |
| 9362-99-120 | 22 mm and 26 mm, Acetabular Insert Trial Case | In distribution |
| 9401-99-120 | In distribution | |
| 6890-99-802 | In distribution | |
| 5791-99 | In distribution | |
| 9380-99-101 | In distribution | |
| 6890-99-942 | Size 5 | In distribution |
| 5223-98 | In distribution | |
| 5223-97 | In distribution | |
| 5789-97 | In distribution | |
| 5791-97 | In distribution | |
| 2348-70 | In distribution | |
| 9380-99-110 | In distribution | |
| 5791-96 | In distribution | |
| 6890-99-930 | In distribution | |
| 8000-99-250 | In distribution | |
| 5791-91 | In distribution | |
| 9363-99-131 | 28 mm Standard Insert Trials Tray | In distribution |
| 5888-00-15 | Depth 38.1 mm | In distribution |
| 1150-95 | In distribution | |
| 5223-93 | In distribution | |
| 5791-96 | In distribution | |
| 9401-99-101 | 22 mm Trials Tray | In distribution |
| 00-5900-096-00 | In distribution | |
| 6890-99-831 | In distribution | |
| 5888-03-20 | Depth 50.8 mm | In distribution |
| 5888-15-60 | Depth 152.4 mm | In distribution |
| 4801-75-40 | In distribution | |
| 9367-99-180 | In distribution | |
| 4903-80 | In distribution | |
| 00-5752-030-00 | In distribution | |
| 5221-91 | In distribution | |
| 9401-99-110 | 26 mm Trials Case | In distribution |
| 5888-00-35 | Depth 88.9 mm | In distribution |
| 2255-62 | In distribution | |
| 5791-98 | In distribution | |
| 9100-99-011 | 6.5mm Cancellous Bone Screw | In distribution |
| 00-2300-020-00 | 4.5, 5.5 mm Percutaneous, Instruments Base and Tray | In distribution |
| 5223-92 | In distribution | |
| 01.00189.209 | In distribution | |
| 5225-85 | In distribution | |
| 5223-91 | In distribution | |
| 5789-96 | In distribution | |
| 6290-99-075 | In distribution | |
| 6890-99-920 | In distribution | |
| 3000-00-999 | In distribution | |
| 6890-99-830 | In distribution | |
| 9365-99-152 | In distribution | |
| 5888-15-50 | Depth 127 mm | In distribution |
| 5791-92 | In distribution | |
| 9366-99-160 | In distribution | |
| 5221-93 | In distribution | |
| 4903-40 | In distribution | |
| 00-5752-016-00 | In distribution | |
| 9364-99-140 | 28 mm and 32 mm, Protrusio Insert Trial Case | In distribution |
| 6890-99-912 | In distribution | |
| 5789-91 | In distribution | |
| 6711-95 | In distribution | |
| 6890-99-940 | Size 5 | In distribution |
| 9354-99-401 | In distribution | |
| 5841-60 | In distribution | |
| 9401-99-111 | 26 mm Trials Tray | In distribution |
| 9354-99-400 | In distribution | |
| 9368-99-181 | 32 mm Standard Insert Trials Tray | In distribution |
| 7712-95 | In distribution | |
| 9380-99-100 | In distribution | |
| 00-5381-099-00 | In distribution | |
| 5791-91 | In distribution | |
| 6611-94 | In distribution | |
| 9362-99-121 | 22 mm Standard and, Hooded Insert Trials Tray | In distribution |
| 6711-85 | In distribution | |
| 5888-12-55 | Depth 139.7 mm | In distribution |
| 00-2366-075-50 | In distribution | |
| 00-4828-095-00 | 2.7 mm Instrument and Implant Case | In distribution |
| 1154-95 | In distribution | |
| 424-85 | 5 and 6 Inch K-Wires | In distribution |
| 1156-85 | In distribution | |
| 424-80 | 3 and 4 Inch K-Wires | In distribution |
| 9365-99-150 | In distribution | |
| 6290-99-076 | In distribution | |
| 9363-99-130 | 28 mm Standard, and Hooded Insert Trial Case | In distribution |
| 7712-98 | In distribution | |
| 6890-99-832 | In distribution | |
| 5888-15-40 | Depth 101.6 mm | In distribution |
| 00-2300-015-00 | 4.5, 5.5, 6.5 mm Screws Base | In distribution |
| 5888-15-25 | Depth 63.5 mm | In distribution |
| 00-7804-000-18 | In distribution | |
| 2611-80 | In distribution | |
| 1156-95 | In distribution | |
| 00-2300-045-00 | 2.0, 2.7, 3.5 mm Screws Base | In distribution |
| 7806-80 | In distribution | |
| 5789-98 | In distribution | |
| 9368-99-182 | 32 mm Hooded Insert Trials Tray | In distribution |
| 5223-96 | In distribution | |
| 5791-97 | In distribution | |
| 00-5853-060-50 | In distribution | |
| 00-2300-025-00 | 4.5, 5.5, 6.5 mm, Instruments Base and Tray | In distribution |
| 5789-93 | In distribution | |
| 5791-93 | In distribution | |
| 00-5853-040-10 | 9 mm – 11 mm Diameter | In distribution |
| 00-5752-035-00 | In distribution | |
| 7806-95 | In distribution | |
| 00-7804-000-20 | In distribution | |
| 5941-75 | In distribution | |
| 00-2366-075-10 | In distribution | |
| 9401-99-100 | 22 mm Trials Case | In distribution |
| 1016 | In distribution | |
| 6890-99-931 | In distribution | |
| 5888-00-55 | Depth 139.7 mm | In distribution |
| 5983-26 | In distribution | |
| 9380-99-111 | In distribution | |
| 5791-98 | In distribution | |
| 7806-99-50 | 12/14 C-Ring Taper | In distribution |
| 7890-99-001 | In distribution | |
| 5791-93 | In distribution | |
| 6275-25 | In distribution | |
| 5791-92 | In distribution | |
| 7712-94 | Size 4.0 – 12.5 Reduced Neck Length, Size 7.5 – 22.5 Original Neck Length | In distribution |
| 2601-15 | In distribution | |
| 7806-99-20 | 12/14 C-Ring Taper Slotted, 36 mm Diameter | In distribution |
| 424 | In distribution | |
| 00-2300-030-00 | 2.0, 2.7, 3.5 mm, Instruments Base and Tray | In distribution |
| 5888-00-45 | Depth 114.3 mm | In distribution |
| 00-7897-047-00 | In distribution | |
| 00-2366-065-00 | In distribution | |
| 424-90 | In distribution | |
| 5841-55 | In distribution | |
| 00-5907-008-00 | In distribution | |
| 5888-15-55 | Depth 139.7 mm | In distribution |
| 6890-99-902 | In distribution | |
| 5901 | In distribution | |
| 00-2366-075-40 | In distribution | |
| 2800-95 | In distribution | |
| 6275-19 | In distribution | |
| 8000-99-100 | In distribution | |
| 9365-99-151 | In distribution | |
| 00-7804-000-30 | In distribution | |
| 6890-99-921 | In distribution | |
| 5223-95 | In distribution | |
| 6890-99-922 | In distribution | |
| 00-4846-090-00 | 3.5 mm Instrument, and Titanium Implant Case | In distribution |
| 00-5752-040-00 | In distribution | |
| 7712-90 | In distribution | |
| 8000-99-400 | In distribution | |
| 00-5853-059-00 | In distribution | |
| 5888-00-25 | Depth 63.5 mm | In distribution |
| 5221-95 | In distribution | |
| 6890-99-901 | In distribution | |
| 00-2366-075-60 | In distribution | |
| 8000-99-300 | In distribution | |
| 804-28 | In distribution | |
| 9362-99-122 | 26 mm Standard and, Hooded Insert Trials Tray | In distribution |
| 6590-99-000 | In distribution | |
| 00-2366-065-20 | In distribution | |
| 6890-99-900 | In distribution | |
| 5888-15-45 | Depth 114.3 mm | In distribution |
| 1155-85 | In distribution | |
| 409-97 | In distribution | |
| 9401-99-121 | In distribution | |
| 00-7804-000-19 | In distribution | |
| 00-1516-002-55 | In distribution | |
| 00-5752-020-00 | In distribution | |
| 00-5752-015-00 | In distribution | |
| 6890-99-911 | In distribution | |
| 5120-90 | In distribution | |
| 6711-90 | In distribution | |
| 5225-92 | Withdrawn | |
| 7806-99-10 | 6 Degree | Withdrawn |
| 7806-99-60 | 6 Degree | Withdrawn |
| 9361-99-110 | Withdrawn | |
| 6603-92 | Withdrawn | |
| 9367-99-170 | Withdrawn | |
| 31-6521-99-31 | 28 mm Head Diameter, Long Neck Plus 3.5 mm | Withdrawn |
| 6603-86 | Withdrawn | |
| 8026-50 | 12/14 Taper | Withdrawn |
| 5591-82 | Withdrawn | |
| 9354-99-501 | Withdrawn | |
| 5591-81 | Withdrawn | |
| 6603-97 | Withdrawn | |
| 6603-91 | Withdrawn | |
| 5591-83 | Withdrawn | |
| 7806-99-40 | Withdrawn | |
| 9200-99-007 | Withdrawn | |
| 9360-99-100 | Withdrawn | |
| 9360-99-101 | Withdrawn | |
| 9400-99-220 | Withdrawn | |
| 9361-99-111 | Withdrawn | |
| 9400-99-219 | Withdrawn | |
| 9367-99-171 | Withdrawn | |
| 9367-99-172 | 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
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-08-11 | Class II | Process control | It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog | 18 units | 2016-03-15 |
| 2014-07-01 | Class II | Device Design | The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not t | 190 units | 2015-06-09 |
| 2014-07-01 | Class II | Device Design | The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not t | 190 units | 2015-06-09 |
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.