Orthex R065-105
GUDID 00841132180099
Ring, 5/8, Large Bone, 105mm
ORTHOPEDIATRICS CORP.
External orthopaedic fixation system, single-use, non-sterile| Primary Device ID | 00841132180099 |
| NIH Device Record Key | c4f42128-ab68-46fe-9934-2be34e5bdb52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orthex |
| Version Model Number | R065-105 |
| Catalog Number | R065-105 |
| 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 | 00841132180099 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151881
FDA Product Code
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
Moist Heat or Steam Sterilization
[00841132180099]
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 [Orthex]
| 00841132180594 | X-Ray Ball Attachment, Large Bone |
| 00841132180501 | Z-Plate, 50mm Ti |
| 00841132180495 | Orthex Z-Plate, Long, Large Bone, 50mm, Titanium |
| 00841132180488 | Z-Plate, 50mm |
| 00841132180471 | Washer, 4mm Square |
| 00841132180464 | Washer, 4mm Rectangular |
| 00841132180457 | Washer, 2mm Square |
| 00841132180440 | Washer, 2mm Rectangular |
| 00841132180433 | Washer, 1mm Square |
| 00841132180426 | Washer, 1mm Rectangular |
| 00841132180419 | Orthex M6 Set Screw, Flat |
| 00841132180402 | Plate, 4 hole, Orthex |
| 00841132180396 | Plate, 3 hole, Orthex |
| 00841132180389 | Plate, 2 hole, Orthex |
| 00841132180372 | Plate, 1 hole, Orthex |
| 00841132180365 | FootPlate 230mm Short |
| 00841132180358 | FootPlate 230mm |
| 00841132180341 | FootPlate 205mm Short |
| 00841132180334 | FootPlate 205mm |
| 00841132180327 | FootPlate 180mm Short |
| 00841132180310 | FootPlate, Large Bone, 180mm |
| 00841132180303 | FootPlate 155mm Short |
| 00841132180297 | FootPlate, Large Bone, 155mm |
| 00841132180280 | FootPlate 130mm Short |
| 00841132180273 | FootPlate, Large Bone, 130mm |
| 00841132180266 | FootPlate 105mm Short |
| 00841132180259 | FootPlate, Large Bone, 105mm |
| 00841132180242 | Ring, Full 280mm |
| 00841132180235 | Ring, Full 255mm |
| 00841132180228 | Ring, Full 230mm |
| 00841132180211 | Ring, Full 205mm |
| 00841132180204 | Ring, Full, Large Bone, 180mm |
| 00841132180198 | Ring, Full, Large Bone, 155mm |
| 00841132180181 | Ring, Full, Large Bone, 130mm |
| 00841132180174 | Ring, Full, Large Bone, 105mm |
| 00841132180167 | Ring, 5/8 280mm |
| 00841132180150 | Ring, 5/8 255mm |
| 00841132180143 | Ring, 5/8 230mm |
| 00841132180136 | Ring, 5/8 205mm |
| 00841132180129 | Ring, 5/8, Large Bone, 180mm |
| 00841132180112 | Ring, 5/8, Large Bone, 155mm |
| 00841132180105 | Ring, 5/8, Large Bone, 130mm |
| 00841132180099 | Ring, 5/8, Large Bone, 105mm |
| 00841132180082 | Ring, Half 280mm |
| 00841132180075 | Ring, Half 255m |
| 00841132180068 | Ring, Half 230mm |
| 00841132180051 | Ring, Half 205mm |
| 00841132180044 | Ring, Half 180mm |
| 00841132180037 | Ring, Half 155mm |
| 00841132180020 | Ring, Half 130mm |
Trademark Results [Orthex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHEX 86919874 5179268 Live/Registered |
Orthex Canada Inc. 2016-02-25 |
 ORTHEX 85800011 not registered Dead/Abandoned |
Orthex, LLC 2012-12-11 |
 ORTHEX 85799899 5041346 Live/Registered |
Orthex, LLC 2012-12-11 |
 ORTHEX 79122656 4570302 Live/Registered |
Oy Orthex Finland Ab. 2012-10-09 |
 ORTHEX 73824791 1599168 Dead/Cancelled |
CHEVRON CHEMICAL COMPANY 1989-09-11 |
 ORTHEX 73784492 1669145 Dead/Cancelled |
CABOT CORPORATION 1989-03-06 |
 ORTHEX 73080775 1052249 Live/Registered |
CHEVRON CHEMICAL COMPANY 1976-03-19 |
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