DJO Surgical
DJO Empowr Kneetm Cemented Stem / TIB AUG Prep, Lower Tray
105manufacturers in China registered for this device type
108catalogue 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 | Encore Medical, L.P., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K172651 |
| Record published | 2018-02-02 |
| Record revised | 2022-09-16 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 803-99-111 | In distribution | |
| 800-99-058 | In distribution | |
| 803-99-140 | In distribution | |
| 800-99-148 | In distribution | |
| 800-99-122 | In distribution | |
| 804-99-015 | In distribution | |
| 803-99-132 | In distribution | |
| 802-05-109 | In distribution | |
| 800-99-108 | In distribution | |
| 804-99-203 | In distribution | |
| 803-99-116 | In distribution | |
| 800-99-028 | In distribution | |
| 800-99-060 | In distribution | |
| 800-99-054 | In distribution | |
| 804-99-200 | In distribution | |
| 800-99-149 | In distribution | |
| 801-05-044 | In distribution | |
| 804-99-118 | In distribution | |
| 800-99-029 | In distribution | |
| 800-99-114 | In distribution | |
| 800-99-042 | In distribution | |
| 803-99-028 | In distribution | |
| 804-99-205 | In distribution | |
| 804-99-124 | In distribution | |
| 804-99-144 | In distribution | |
| 800-99-057 | In distribution | |
| 800-99-064 | In distribution | |
| 800-99-162 | In distribution | |
| 800-99-037 | In distribution | |
| 804-99-140 | In distribution | |
| 800-99-012 | In distribution | |
| 800-99-141 | In distribution | |
| 800-99-118 | In distribution | |
| 800-99-167 | In distribution | |
| 800-99-018 | In distribution | |
| 800-99-115 | In distribution | |
| 803-99-120 | In distribution | |
| 800-99-030 | In distribution | |
| 800-99-034 | In distribution | |
| 803-99-119 | In distribution | |
| 804-99-011 | In distribution | |
| 803-99-172 | In distribution | |
| 804-99-119 | In distribution | |
| 800-99-120 | In distribution | |
| 804-99-020 | In distribution | |
| 803-99-114 | In distribution | |
| 804-99-117 | In distribution | |
| 804-99-010 | In distribution | |
| 800-99-152 | In distribution | |
| 802-01-028 | In distribution | |
| 800-99-163 | In distribution | |
| 804-99-121 | In distribution | |
| 804-99-138 | In distribution | |
| 804-99-131 | In distribution | |
| 800-99-035 | In distribution | |
| 800-99-117 | In distribution | |
| 803-99-133 | In distribution | |
| 804-99-032 | In distribution | |
| 800-99-161 | In distribution | |
| 800-99-160 | In distribution | |
| 800-99-019 | In distribution | |
| 804-99-122 | In distribution | |
| 803-99-115 | In distribution | |
| 804-99-141 | In distribution | |
| 800-99-032 | In distribution | |
| 800-99-138 | In distribution | |
| 800-99-116 | In distribution | |
| 800-99-135 | In distribution | |
| 800-99-194 | In distribution | |
| 803-99-130 | In distribution | |
| 803-99-117 | In distribution | |
| 804-99-145 | In distribution | |
| 804-99-129 | In distribution | |
| 803-99-095 | In distribution | |
| 804-99-142 | In distribution | |
| 804-99-137 | In distribution | |
| 800-99-164 | In distribution | |
| 804-99-139 | In distribution | |
| 800-99-134 | In distribution | |
| 804-99-130 | In distribution | |
| 800-99-121 | In distribution | |
| 800-99-056 | In distribution | |
| 803-99-096 | In distribution | |
| 800-99-055 | In distribution | |
| 800-99-052 | In distribution | |
| 804-99-135 | In distribution | |
| 803-99-118 | In distribution | |
| 803-99-060 | In distribution | |
| 804-99-204 | In distribution | |
| 804-99-120 | In distribution | |
| 800-99-024 | In distribution | |
| 803-99-131 | In distribution | |
| 804-99-025 | In distribution | |
| 804-99-201 | In distribution | |
| 804-99-202 | In distribution | |
| 803-99-027 | In distribution | |
| 800-99-159 | In distribution | |
| 804-99-024 | In distribution | |
| 803-99-113 | In distribution | |
| 800-99-139 | In distribution | |
| 800-99-041 | In distribution | |
| 800-99-107 | In distribution | |
| 800-99-137 | In distribution | |
| 800-99-123 | In distribution | |
| 804-99-136 | In distribution | |
| 804-99-143 | In distribution | |
| 800-99-151 | In distribution | |
| 804-99-030 | 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
1 of these is 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 |
|---|---|---|---|---|
| 2025-07-18 | Class II | Device Design | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | 439 kits |
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.