| Primary Device ID | 08806373883538 |
| NIH Device Record Key | 1cae9219-16b2-4a7e-8106-a7f05901bbfc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LOSPA Knee System |
| Version Model Number | 01.62.196 |
| Company DUNS | 688739895 |
| Company Name | Corentec Co., Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com | |
| Phone | +820415857114 |
| hckoh@corentec.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806373883538 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
[08806373883538]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2022-03-22 |
| Device Publish Date | 2018-01-31 |
| 08806373890086 | Pin driver |
| 08806373890062 | Pin holder |
| 08806373889813 | Tibial reamer |
| 08806373878138 | Reamer Φ18 |
| 08806373878121 | Reamer Φ17 |
| 08806373878114 | Reamer Φ16 |
| 08806373878107 | Reamer Φ15 |
| 08806373878091 | Reamer Φ14 |
| 08806373878084 | Reamer Φ13 |
| 08806373878077 | Reamer Φ12 |
| 08806373878060 | Reamer Φ11 |
| 08806373878053 | Reamer Φ10 |
| 08806373878046 | Reamer Φ09 |
| 08806373875311 | Offset Reamer ∅18 |
| 08806373875304 | Offset Reamer ∅17 |
| 08806373875298 | Offset Reamer ∅16 |
| 08806373875281 | Offset Reamer ∅15 |
| 08806373875274 | Offset Reamer ∅14 |
| 08806373875267 | Offset Reamer ∅13 |
| 08806373875250 | Offset Reamer ∅12 |
| 08806373875243 | Offset Reamer ∅11 |
| 08806373875236 | Offset Reamer ∅10 |
| 08806373875229 | Offset Reamer ∅9 |
| 08806373898570 | Tibial baseplate trial-Fixed-SZ 16 |
| 08806373898563 | Tibial baseplate trial-Fixed-SZ 14 |
| 08806373898556 | Tibial baseplate trial-Fixed-SZ 12 |
| 08806373898549 | Tibial baseplate trial-Fixed-SZ 6 |
| 08806373898532 | Tibial insert trial-Fixed-PS-SZ 16-26T |
| 08806373898525 | Tibial insert trial-Fixed-PS-SZ 16-24T |
| 08806373898518 | Tibial insert trial-Fixed-PS-SZ 16-22T |
| 08806373898501 | Tibial insert trial-Fixed-PS-SZ 16-20T |
| 08806373898495 | Tibial insert trial-Fixed-PS-SZ 16-18T |
| 08806373898488 | Tibial insert trial-Fixed-PS-SZ 16-16T |
| 08806373898471 | Tibial insert trial-Fixed-PS-SZ 16-14T |
| 08806373898464 | Tibial insert trial-Fixed-PS-SZ 16-12T |
| 08806373898457 | Tibial insert trial-Fixed-PS-SZ 16-10T |
| 08806373898440 | Tibial insert trial-Fixed-PS-SZ 16-8T |
| 08806373898433 | Tibial insert trial-Fixed-PS-SZ 14-26T |
| 08806373898426 | Tibial insert trial-Fixed-PS-SZ 14-24T |
| 08806373898419 | Tibial insert trial-Fixed-PS-SZ 14-22T |
| 08806373898402 | Tibial insert trial-Fixed-PS-SZ 14-20T |
| 08806373898396 | Tibial insert trial-Fixed-PS-SZ 14-18T |
| 08806373898389 | Tibial insert trial-Fixed-PS-SZ 14-16T |
| 08806373898372 | Tibial insert trial-Fixed-PS-SZ 14-14T |
| 08806373898365 | Tibial insert trial-Fixed-PS-SZ 14-12T |
| 08806373898358 | Tibial insert trial-Fixed-PS-SZ 14-10T |
| 08806373898341 | Tibial insert trial-Fixed-PS-SZ 14-8T |
| 08806373898334 | Tibial insert trial-Fixed-PS-SZ 12-26T |
| 08806373898327 | Tibial insert trial-Fixed-PS-SZ 12-24T |
| 08806373898310 | Tibial insert trial-Fixed-PS-SZ 12-22T |