DJO Surgical
Special, Empowr REV Knee Monoblock Tibial Tray Trial, SZ 10L
21manufacturers in China registered for this device type
371catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 21. All 21 manufacturers in China registered for Template
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K171991 |
| Record published | 2025-01-17 |
| Record revised | 2024-07-12 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 801-05-942 | In distribution | |
| 804-09-076 | In distribution | |
| 803-17-364 | In distribution | |
| 800-88-114 | In distribution | |
| 803-17-404 | In distribution | |
| 801-05-982 | In distribution | |
| 804-88-025 | In distribution | |
| 800-02-363 | In distribution | |
| S-201687 | In distribution | |
| 803-88-147 | In distribution | |
| 803-10-006 | In distribution | |
| 803-10-005 | In distribution | |
| 801-03-016 | In distribution | |
| 803-17-281 | In distribution | |
| S-201936 | In distribution | |
| 800-08-005 | In distribution | |
| 801-05-967 | In distribution | |
| 804-09-082 | In distribution | |
| 804-09-060 | In distribution | |
| S-201705 | In distribution | |
| 801-01-124 | In distribution | |
| 801-01-714 | In distribution | |
| 801-01-223 | In distribution | |
| 801-01-123 | In distribution | |
| 804-09-064 | In distribution | |
| S-201709 | In distribution | |
| 804-09-053 | In distribution | |
| 801-07-101 | In distribution | |
| S-201708 | In distribution | |
| 803-17-323 | In distribution | |
| S-201672 | In distribution | |
| 804-06-302 | In distribution | |
| 801-05-955 | In distribution | |
| 801-05-992 | In distribution | |
| S-201693 | In distribution | |
| 801-01-724 | In distribution | |
| 804-09-061 | In distribution | |
| 801-05-994 | In distribution | |
| 801-05-965 | In distribution | |
| 804-01-063 | In distribution | |
| 804-88-021 | In distribution | |
| 804-01-062 | In distribution | |
| 801-07-103 | In distribution | |
| S-201695 | In distribution | |
| 801-05-953 | In distribution | |
| 801-05-949 | In distribution | |
| 800-88-106 | In distribution | |
| 804-01-066 | In distribution | |
| 801-01-713 | In distribution | |
| 801-05-951 | In distribution | |
| 803-17-284 | In distribution | |
| 803-17-362 | In distribution | |
| 800-05-506 | In distribution | |
| 803-42-36D | In distribution | |
| 801-01-701 | In distribution | |
| S-201707 | In distribution | |
| 803-17-443 | In distribution | |
| 804-09-083 | In distribution | |
| 800-88-102 | In distribution | |
| 803-44-36D | In distribution | |
| 801-05-962 | In distribution | |
| S-201800 | In distribution | |
| 801-01-136 | In distribution | |
| 804-06-301 | In distribution | |
| S-201935 | In distribution | |
| S-201723 | In distribution | |
| 803-42-40F | In distribution | |
| 803-10-004 | In distribution | |
| 801-05-968 | In distribution | |
| 804-09-087 | In distribution | |
| 801-05-971 | In distribution | |
| S-201724 | In distribution | |
| 801-05-984 | In distribution | |
| 800-05-302 | In distribution | |
| 801-05-943 | In distribution | |
| 804-09-068 | In distribution | |
| 800-05-303 | In distribution | |
| S-201934 | In distribution | |
| 800-01-285 | In distribution | |
| 801-05-159 | In distribution | |
| 803-41-44H | In distribution | |
| 800-07-302 | In distribution | |
| S-201719 | In distribution | |
| 801-01-712 | In distribution | |
| 804-88-024 | In distribution | |
| 803-17-363 | In distribution | |
| 800-05-304 | In distribution | |
| S-201804 | In distribution | |
| 803-17-444 | In distribution | |
| 801-05-963 | In distribution | |
| 800-07-304 | In distribution | |
| 801-01-708 | In distribution | |
| 804-09-014 | In distribution | |
| 801-05-996 | In distribution | |
| 801-05-991 | In distribution | |
| 801-01-129 | In distribution | |
| 801-05-976 | In distribution | |
| 801-05-970 | In distribution | |
| 800-08-004 | In distribution | |
| 803-15-240 | In distribution | |
| 801-07-104 | In distribution | |
| S-201721 | In distribution | |
| 801-05-954 | In distribution | |
| 804-09-008 | In distribution | |
| 803-43-36D | In distribution | |
| 801-05-978 | In distribution | |
| 804-09-005 | In distribution | |
| 804-09-067 | In distribution | |
| 803-88-146 | In distribution | |
| 800-01-282 | In distribution | |
| 804-06-334 | In distribution | |
| 801-05-987 | In distribution | |
| 801-01-707 | In distribution | |
| 803-15-258 | In distribution | |
| 804-09-088 | In distribution | |
| 801-05-981 | In distribution | |
| 803-04-157 | In distribution | |
| 801-05-948 | In distribution | |
| 801-05-059 | In distribution | |
| 804-09-065 | In distribution | |
| 804-09-054 | In distribution | |
| 800-01-331 | In distribution | |
| 800-88-119 | In distribution | |
| 801-05-974 | In distribution | |
| S-201799 | In distribution | |
| S-201797 | In distribution | |
| 804-09-084 | In distribution | |
| 803-17-324 | In distribution | |
| 801-01-717 | In distribution | |
| 804-06-314 | In distribution | |
| 800-08-003 | In distribution | |
| 801-01-128 | In distribution | |
| 801-05-990 | In distribution | |
| S-201933 | In distribution | |
| 803-88-000 | In distribution | |
| 801-01-727 | In distribution | |
| 800-05-306 | In distribution | |
| 801-01-728 | In distribution | |
| 801-05-983 | In distribution | |
| 803-03-233 | In distribution | |
| 801-01-711 | In distribution | |
| 801-04-008 | In distribution | |
| 800-01-343 | In distribution | |
| 801-01-704 | In distribution | |
| 803-17-441 | In distribution | |
| 804-06-342 | In distribution | |
| 804-09-052 | In distribution | |
| 804-88-026 | In distribution | |
| S-201937 | In distribution | |
| 801-03-014 | In distribution | |
| 800-05-322 | In distribution | |
| S-201746 | In distribution | |
| S-201702 | In distribution | |
| 804-09-056 | In distribution | |
| S-201740 | In distribution | |
| 801-03-015 | In distribution | |
| 801-05-988 | In distribution | |
| 801-05-958 | In distribution | |
| 804-09-013 | In distribution | |
| 804-09-085 | In distribution | |
| S-201747 | In distribution | |
| 801-05-997 | In distribution | |
| 804-09-015 | In distribution | |
| 804-09-066 | In distribution | |
| 804-09-075 | In distribution | |
| 804-09-074 | In distribution | |
| 804-09-059 | In distribution | |
| S-201931 | In distribution | |
| 804-09-079 | In distribution | |
| 803-17-401 | In distribution | |
| 800-88-117 | In distribution | |
| S-201802 | In distribution | |
| S-201694 | In distribution | |
| 804-09-016 | In distribution | |
| 800-07-202 | In distribution | |
| S-201745 | In distribution | |
| 801-05-989 | In distribution | |
| 803-43-32B | In distribution | |
| 800-01-342 | In distribution | |
| S-201710 | In distribution | |
| S-201938 | In distribution | |
| 804-09-011 | In distribution | |
| 803-43-44H | In distribution | |
| S-201698 | In distribution | |
| 803-17-361 | In distribution | |
| S-201700 | In distribution | |
| 801-07-102 | In distribution | |
| 801-05-162 | In distribution | |
| 803-17-442 | In distribution | |
| 801-05-977 | In distribution | |
| S-201706 | In distribution | |
| 801-01-718 | In distribution | |
| 800-05-314 | In distribution | |
| S-201741 | In distribution | |
| 804-09-062 | In distribution | |
| 801-01-726 | In distribution | |
| S-201673 | In distribution | |
| 801-05-975 | In distribution | |
| S-201704 | In distribution | |
| 801-05-944 | In distribution | |
| 803-17-322 | In distribution | |
| 804-09-057 | In distribution | |
| 800-01-283 | In distribution | |
| 801-05-952 | In distribution | |
| S-201798 | In distribution | |
| 801-03-013 | In distribution | |
| 804-06-341 | In distribution | |
| 800-05-311 | In distribution | |
| S-201688 | In distribution | |
| 801-05-969 | In distribution | |
| 804-09-078 | In distribution | |
| 803-03-231 | In distribution | |
| 804-06-315 | In distribution | |
| 801-01-720 | In distribution | |
| 800-05-305 | In distribution | |
| S-201699 | In distribution | |
| 804-09-012 | In distribution | |
| 801-05-959 | In distribution | |
| 801-05-964 | In distribution | |
| 801-01-710 | In distribution | |
| 801-05-061 | In distribution | |
| 801-01-191 | In distribution | |
| 800-05-316 | In distribution | |
| 804-09-055 | In distribution | |
| 801-05-972 | In distribution | |
| 804-09-069 | In distribution | |
| 804-06-339 | In distribution | |
| 803-41-40F | In distribution | |
| 804-09-003 | In distribution | |
| 800-04-028 | In distribution | |
| 804-09-080 | In distribution | |
| 800-01-284 | In distribution | |
| 800-01-309 | In distribution | |
| 804-01-064 | In distribution | |
| 800-08-006 | In distribution | |
| 801-01-703 | In distribution | |
| S-201743 | In distribution | |
| S-201806 | In distribution | |
| 803-17-402 | In distribution | |
| 804-09-010 | In distribution | |
| 801-01-706 | In distribution | |
| 804-09-086 | In distribution | |
| 800-08-001 | In distribution | |
| 801-05-966 | In distribution | |
| 801-01-130 | In distribution | |
| 801-05-995 | In distribution | |
| S-201742 | In distribution | |
| 804-09-004 | In distribution | |
| 803-84-128 | In distribution | |
| 804-09-081 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Attune | Depuy (Ireland) | 1,385 |
| Template | Exactech, Inc. | 1,277 |
| 4WEB Medical | 4WEB Inc. | 991 |
| Evolution® | Microport Orthopedics Inc. | 966 |
| Template | Zimmer, Inc. | 792 |
| Advance® | Microport Orthopedics Inc. | 644 |
| Apex Knee System | Omni Life Science, Inc. | 635 |
| Profemur® | Microport Orthopedics Inc. | 591 |
| Link Instruments – Trial implants and size gauges | Waldemar Link GmbH & Co. KG | 549 |
| Template | Synthes Gmbh | 516 |
| Optetrak Logic | Exactech, Inc. | 512 |
| Template | Depuy Spine, Inc. | 451 |
Showing 12 of 2,940. All products under Template
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 | Closed |
|---|---|---|---|---|---|
| 2015-06-24 | Class II | Component design/selection | The markings on the distal face of the instruments are mis-oriented by 180. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, | 10 units | 2016-06-24 |
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.