HLS KneeTec MDI325
GUDID 05056139220586
Preparation Plate Holder
CORIN LTD
Orthopaedic prosthesis implantation instrument, reusable| Primary Device ID | 05056139220586 |
| NIH Device Record Key | 5a50a3d1-52ec-4c9c-9e9d-50df473f846c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HLS KneeTec |
| Version Model Number | MDI325 |
| Catalog Number | MDI325 |
| Company DUNS | 295437313 |
| Company Name | CORIN 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 | false |
| 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 |
Customer Support Contacts
| Phone | +330456608978 |
| severine.siracusa@coringroup.c | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com | |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05056139220586 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K094013
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
[05056139220586]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-28 |
| Device Publish Date | 2018-08-28 |
On-Brand Devices [HLS KneeTec]
| 05056139233685 | Hexagonal screwdriver hex 3.5 |
| 05056139233678 | Patellar Impaction System |
| 05056139226052 | Autodrilling pin dia 3,5mm Lg 50mm |
| 05056139225970 | Autodrilling pin dia 3,5mm Lg 80mm |
| 05056139225017 | Oscillating saw blade 1.27mm Stryker B |
| 05056139225000 | Oscillating saw blade 1.27mm AO Müller |
| 05056139224997 | Oscillating saw blade 1.27mm Hall-Linvatec |
| 05056139224980 | Oscillating saw blade 1.27mm Aesculap |
| 05056139222337 | Fin Impactor Guide 1 |
| 05056139222320 | IM Rod Extraction Handle |
| 05056139222313 | Cemented stem for punch |
| 05056139222306 | Fin Impactor Guide 5-6-7-8 |
| 05056139222290 | Fin Impactor Guide 2-3-4 |
| 05056139222283 | Tibial stylus |
| 05056139222276 | Spacer holder Th. 6mm |
| 05056139221613 | trial cemented long plug cutter |
| 05056139221590 | Trial cemented plug cutter |
| 05056139221460 | 10mm th. Stop |
| 05056139221453 | 5mm th. Stop |
| 05056139221446 | Stem reamer |
| 05056139221422 | Fin Impactor 5-6-7-8 |
| 05056139221415 | Fin Impactor 2-3-4 |
| 05056139221408 | Fin Impactor 1 |
| 05056139221392 | Threaded pins dia 3,5mm Length 50mm |
| 05056139221385 | 4 in 1 Cutting Guide S.7 |
| 05056139221378 | 4 in 1 Cutting Guide S.6 |
| 05056139221361 | 4 in 1 Cutting Guide S.5 |
| 05056139221354 | 4 in 1 Cutting Guide S.4 |
| 05056139221347 | 4 in 1 Cutting Guide S.3 |
| 05056139221330 | 4 in 1 Cutting Guide S.2 |
| 05056139221040 | Patella ring L |
| 05056139221033 | Patella ring M |
| 05056139221026 | Patella ring Small |
| 05056139221019 | Patella ring X-Small |
| 05056139221002 | Patella drill guide |
| 05056139220999 | Patellar Reamer Blade Ø42 |
| 05056139220982 | Pin puller |
| 05056139220975 | Pin extractor |
| 05056139220968 | Posterior ref. drill guide |
| 05056139220951 | Anterior ref. drill guide |
| 05056139220944 | Gap gauge |
| 05056139220937 | Sizing guide Left |
| 05056139220920 | Sizing guide Right |
| 05056139220913 | Distraction plate |
| 05056139220906 | Distal Cutting Guide Support MIS |
| 05056139220890 | Distal Cutting Guide MIS |
| 05056139220883 | Cutting Pin dia 3,5mm Length 100mm |
| 05056139220876 | Osteotome |
| 05056139220869 | Impactor Handle |
| 05056139220852 | Distal Cutting Guide on Pins |
Trademark Results [HLS KneeTec]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HLS KNEETEC 77617668 3688507 Live/Registered |
CORIN LIMITED 2008-11-19 |
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