STATIX 301-065-180
GUDID 00841132140956
Ring, Statix 5/8 180mm Black
ORTHOPEDIATRICS CORP.
External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use| Primary Device ID | 00841132140956 |
| NIH Device Record Key | 6c539cde-7030-493c-ab55-a53049e8bf9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STATIX |
| Version Model Number | 301-065-180 |
| Catalog Number | 301-065-180 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| 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 | 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 | 00841132140956 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052196
FDA Product Code
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
[00841132140956]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-09 |
| Device Publish Date | 2020-02-28 |
On-Brand Devices [STATIX]
| 00841132141045 | FootPlate, Statix 210mm Black |
| 00841132141038 | FootPlate, Statix 180mm Black |
| 00841132141021 | FootPlate, Statix 160mm Black |
| 00841132141014 | FootPlate, Statix 140mm Black |
| 00841132141007 | Ring, Statix Full 210mm Black |
| 00841132140994 | Ring, Statix Full 180mm Black |
| 00841132140987 | Ring, Statix Full 160mm Black |
| 00841132140970 | Ring, Statix Full 140mm Black |
| 00841132140963 | Ring, Statix 5/8 210mm Black |
| 00841132140956 | Ring, Statix 5/8 180mm Black |
| 00841132140949 | Ring, Statix 5/8 160mm Black |
| 00841132140932 | Ring, Statix 5/8 140mm Black |
| 00841132140925 | Ring, Statix Half 210mm Black |
| 00841132140918 | Ring, Statix Half 180mm Black |
| 00841132140901 | Ring, Statix Half 160mm Black |
| 00841132140895 | Ring, Statix Half 140mm Black |
| 00841132140888 | Ring, Statix 3/8 210mm Black |
| 00841132140871 | Ring, Statix 3/8 180mm Black |
| 00841132140864 | Ring, Statix 3/8 160mm Black |
| 00841132140857 | Ring, Statix 3/8 140mm Black |
Trademark Results [STATIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STATIX 85283628 4422318 Live/Registered |
Biotix Inc. 2011-04-01 |
 STATIX 75374398 2237797 Live/Registered |
CONTINENTAL CRUSHING & CONVEYING INC. 1997-10-14 |
 STATIX 73669128 1488898 Dead/Cancelled |
SIERRA GEOPHSICS, INC. 1987-06-29 |
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