Enduro
Enduro Femur Spacer Post/Dist F3 12X12MM
7manufacturers in China registered for this device type
91catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 4 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2025-11-13 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-01-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NB012K | Figure / Size : T2 | Withdrawn |
| NB019K | Left/Right : right | Withdrawn |
| NB056K | Height : 8.000 MM | Withdrawn |
| NB057K | Height : 12.000 MM | Withdrawn |
| NR892M | Figure / Size : F3 | Withdrawn |
| NR882M | Height : 14.000 MM | Withdrawn |
| NB066K | Figure / Size : T3 | Withdrawn |
| NR860K | Withdrawn | |
| NR891M | Figure / Size : F3 | Withdrawn |
| NR881M | Height : 12.000 MM | Withdrawn |
| NR880M | Height : 10.000 MM | Withdrawn |
| NR377K | Implant Fixation : cemented | Withdrawn |
| NR895M | Figure / Size : F3 | Withdrawn |
| NB067K | Height : 12.000 MM | Withdrawn |
| NR897M | Height : 24.000 MM | Withdrawn |
| NB037K | Implant Fixation : cemented | Withdrawn |
| NB035K | Height : 4.000 MM | Withdrawn |
| NR887M | Height : 24.000 MM | Withdrawn |
| NR876M | Height : 22.000 MM | Withdrawn |
| NB026K | Height : 8.000 MM | Withdrawn |
| NR593K | Implant Fixation : cemented | Withdrawn |
| NR386K | Implant Fixation : cemented | Withdrawn |
| NB013K | Figure / Size : T3 | Withdrawn |
| NB076K | Implant Fixation : cemented | Withdrawn |
| NR596K | Implant Fixation : cemented | Withdrawn |
| NR867K | Figure / Size : F3 | Withdrawn |
| NR873M | Figure / Size : F1 | Withdrawn |
| NR883M | Height : 16.000 MM | Withdrawn |
| NR864K | Height : 4.000 MM | Withdrawn |
| NB058K | Height : 16.000 MM | Withdrawn |
| NR886M | Figure / Size : F2 | Withdrawn |
| NB048K | Figure / Size : T2 | Withdrawn |
| NR597K | Implant Fixation : cemented | Withdrawn |
| NR598K | Implant Fixation : cemented | Withdrawn |
| NR894M | Figure / Size : F3 | Withdrawn |
| NB027K | Implant Fixation : cemented | Withdrawn |
| NR874M | Figure / Size : F1 | Withdrawn |
| NR861K | Height : 4.000 MM | Withdrawn |
| NB077K | Figure / Size : T3 | Withdrawn |
| NR877M | Figure / Size : F1 | Withdrawn |
| NR871M | Figure / Size : F1 | Withdrawn |
| NR366K | Implant Fixation : cemented | Withdrawn |
| NB065K | Figure / Size : T3 | Withdrawn |
| NB068K | Height : 16.000 MM | Withdrawn |
| NR885M | Figure / Size : F2 | Withdrawn |
| NR870M | Height : 10.000 MM | Withdrawn |
| NR865K | Figure / Size : F2 | Withdrawn |
| NR890M | Height : 10.000 MM | Withdrawn |
| NR591K | Figure / Size : F2 | Withdrawn |
| NR397K | Figure / Size : F1 | Withdrawn |
| NR862K | Figure / Size : F1 | Withdrawn |
| NB045K | Height : 4.000 MM | Withdrawn |
| NR396K | Implant Fixation : cemented | Withdrawn |
| NR367K | Implant Fixation : cemented | Withdrawn |
| NB075K | Height : 4.000 MM | Withdrawn |
| NR378K | Figure / Size : F2 | Withdrawn |
| NR592K | Figure / Size : F2 | Withdrawn |
| NR389K | Implant Fixation : cemented | Withdrawn |
| NB011K | Figure / Size : T1 | Withdrawn |
| NR884M | Height : 18.000 MM | Withdrawn |
| NB047K | Implant Fixation : cemented | Withdrawn |
| NR599K | Implant Fixation : cemented | Withdrawn |
| NR869K | Figure / Size : F3 | Withdrawn |
| NB015K | Left/Right : left | Withdrawn |
| NB016K | Left/Right : left | Withdrawn |
| NB028K | Height : 16.000 MM | Withdrawn |
| NB036K | Height : 8.000 MM | Withdrawn |
| NR868K | Figure / Size : F3 | Withdrawn |
| NB018K | Left/Right : right | Withdrawn |
| NR379K | Implant Fixation : cemented | Withdrawn |
| NR893M | Height : 16.000 MM | Withdrawn |
| NR594K | Implant Fixation : cemented | Withdrawn |
| NB017K | Left/Right : right | Withdrawn |
| NB038K | Implant Fixation : cemented | Withdrawn |
| NR863K | Figure / Size : F1 | Withdrawn |
| NR896M | Figure / Size : F3 | Withdrawn |
| NR590K | Implant Fixation : cemented | Withdrawn |
| NR387K | Implant Fixation : cemented | Withdrawn |
| NR872M | Figure / Size : F1 | Withdrawn |
| NB055K | Figure / Size : T2 | Withdrawn |
| NR369K | Implant Fixation : cemented | Withdrawn |
| NR866K | Height : 12.000 MM | Withdrawn |
| NB078K | Height : 16.000 MM | Withdrawn |
| NB046K | Implant Fixation : cemented | Withdrawn |
| NB014K | Left/Right : left | Withdrawn |
| NR595K | Implant Fixation : cemented | Withdrawn |
| NR388K | Figure / Size : F3 | Withdrawn |
| NR368K | Figure / Size : F1 | Withdrawn |
| NB025K | Figure / Size : T1 | Withdrawn |
| NR376K | Figure / Size : F2 | Withdrawn |
| NR875M | Height : 20.000 MM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 324 |
| Endo-Model Modular Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 291 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 263 |
| Evolution | Microport Orthopedics Inc. | 223 |
| Legion | Smith & Nephew, Inc. | 222 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 211 |
| Ustar II Knee System | United Orthopedic Corp. | 185 |
| “united” Ustar II Knee System | United Orthopedic Corp. | 162 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 157 |
| Finn Knee System | Biomet Orthopedics | 138 |
| NexGen | Zimmer, Inc. | 119 |
| Triathlon | Howmedica Osteonics Corp | 106 |
Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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.