| Primary Device ID | 08800068960016 |
| NIH Device Record Key | d6d77906-9420-466f-86ce-61d0b87b677d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lospa Surgical Instruments |
| Version Model Number | KA.DFC.E009 |
| 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 | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800068960016 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
[08800068960016]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-08 |
| Device Publish Date | 2024-10-31 |
| 08800068961396 | Patella Clamp |
| 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 |