HLS KNEETEC
GUDID 03700386933127
TORNIER
Uncoated knee femur prosthesis, metallic| Primary Device ID | 03700386933127 |
| NIH Device Record Key | e6d313f4-6fc1-4056-b77f-afe131ab04ac |
| Commercial Distribution Discontinuation | 2017-11-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HLS KNEETEC |
| Version Model Number | GDI016 |
| Company DUNS | 260324876 |
| Company Name | TORNIER |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +330476613500 |
| order@tornier.com |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700386933127 [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 | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [HLS KNEETEC]
Trademark Results [HLS KNEETEC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HLS KNEETEC 77617668 3688507 Live/Registered |
CORIN LIMITED 2008-11-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.