CENTROLOCK XTI06020
GUDID 03700879516028
Centrolock Stemless trial sizer Right
NOVASTEP
General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable| Primary Device ID | 03700879516028 |
| NIH Device Record Key | 328f85ed-2ab9-4dfb-9b9d-34489df2ea45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CENTROLOCK |
| Version Model Number | XTI06020 |
| Catalog Number | XTI06020 |
| Company DUNS | 264255288 |
| Company Name | NOVASTEP |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700879516028 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192356
FDA Product Code
| HRS | Plate, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
[03700879516028]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-29 |
| Device Publish Date | 2021-07-21 |
On-Brand Devices [CENTROLOCK]
| 03700879516028 | Centrolock Stemless trial sizer Right |
| 03700879516011 | Centrolock Stemless trial sizer Left |
Trademark Results [CENTROLOCK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CENTROLOCK 88391360 not registered Live/Pending |
NOVASTEP 2019-04-18 |
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