| Primary Device ID | 08806373890079 | 
| NIH Device Record Key | 288b29fe-f497-4807-a1af-849fa26610ff | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | LOSPA Surgical Instruments | 
| Version Model Number | 01.61.219 | 
| Company DUNS | 688739895 | 
| Company Name | Corentec Co., Ltd | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | |
| Phone | +82269374902 | 
| ra@corentec.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08806373890079 [Primary] | 
| HWA | Impactor | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
[08806373890079]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-08-18 | 
| Device Publish Date | 2025-08-08 | 
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| 08800068959669 | Femoral Condyle Drill | 
| 08800068947574 | Tibial Cutting Guide RT DEG3_KR | 
| 08800068947567 | Tibial Cutting Guide LT DEG3_KR | 
| 08806373890123 | Baseplate Headed Pin | 
| 08806373889660 | Tibial Telescopic Assy | 
| 08806373889271 | EM Alignment Rod 400mm | 
| 08806373898648 | Chamfer Cutting Guide SZ 12 | 
| 08806373892547 | Tibial Protector | 
| 08806373892530 | PS Box Chisel | 
| 08806373890116 | Universal Extractor | 
| 08806373890109 | Slap Hammer | 
| 08806373890093 | Pin Extractor | 
| 08806373890031 | Bone File | 
| 08806373889776 | Tibial Keel Punch Guide | 
| 08806373889639 | Femoral Redriller | 
| 08806373889578 | PS Box Cutting Guide SZ 11 | 
| 08806373889554 | PS Box Cutting Guide SZ 09 | 
| 08806373889530 | PS Box Cutting Guide SZ 07 | 
| 08806373889516 | PS Box Cutting Guide SZ 05 | 
| 08806373889509 | PS Box Cutting Guide SZ 04 | 
| 08806373889493 | PS Box Cutting Guide SZ 03 | 
| 08806373889325 | Angel Wing | 
| 08806373889318 | Distal Cutting Guide | 
| 08800017205878 | Chamfer Cutting Guide SZ 14 | 
| 08800017205861 | Chamfer Cutting Guide SZ 11 | 
| 08800017205854 | Chamfer Cutting Guide SZ 09 | 
| 08800017205847 | Chamfer Cutting Guide SZ 07 | 
| 08800017205830 | Chamfer Cutting Guide SZ 05 | 
| 08800017205823 | Chamfer Cutting Guide SZ 04 | 
| 08800017205816 | Chamfer Cutting Guide SZ 03 | 
| 08800017205311 | Patella Clamp | 
| 08800017205281 | Patella Peg Drill Guide Head PCD 16 | 
| 08800017205274 | Patella Peg Drill Guide Head PCD12 | 
| 08800068977588 | Tibial Stylus (Adjustable) | 
| 08800068959843 | Spike Tibial Tower | 
| 08800068958853 | KA.DF0.E111 | 
| 08800068958846 | Start Awl | 
| 08800068960368 | TEA Checker | 
| 08800068960047 | Chamfer Cutting Guide #14 | 
| 08800068960030 | Chamfer Cutting Guide #12 | 
| 08800068960023 | Chamfer Cutting Guide #11 | 
| 08800068960016 | Chamfer Cutting Guide #09 | 
| 08800068960009 | Chamfer Cutting Guide #07 | 
| 08800068959997 | Chamfer Cutting Guide #05 | 
| 08800068959980 | Chamfer Cutting Guide #04 | 
| 08800068959973 | Chamfer Cutting Guide #03 | 
| 08800068959607 | EM Alignment Assembly Rod | 
| 08800068959591 | EM Assembly Rod | 
| 08800017299006 | Distal Cutting Guide S Phase2 |