RetroFix CTM001055
GUDID 00850005757658
Surgical K-Wire Kirshner wire or pins Guide Wire 1.3mm Diameter 300 mm Length
RETROFIX SCREWS, LLC
Orthopaedic bone wire| Primary Device ID | 00850005757658 |
| NIH Device Record Key | dd8e1d07-f1cf-4553-97ba-7c7e7a7d359b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RetroFix |
| Version Model Number | K-Wire, 1.3mm x 300mm PK 25 |
| Catalog Number | CTM001055 |
| Company DUNS | 069485021 |
| Company Name | RETROFIX SCREWS, LLC |
| 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 | true |
| 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 | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com | |
| Phone | 19804328412 |
| tmiller@retrofixscrews.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005757658 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200226
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
[00850005757658]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-07 |
| Device Publish Date | 2020-12-30 |
On-Brand Devices [RetroFix ]
| 00850005757467 | CANNULATED TAPERED SCREW OVERALL LENGTH 100MM PROXIMAL DIAMETER 5MM PROXIMAL LENGHT 40MM DIST |
| 00850005757764 | Surgical K-Wire Kirshner wire or pins Guide Wire 1.3mm Diameter 300 mm Length |
| 00850005757757 | Surgical K-Wire Kirshner wire or pins Guide Wire 1.3mm Diameter 225mm Length |
| 00850005757733 | Instrument Drawer, lower, tray replacement for instrument tray |
| 00850005757726 | instrument drawer, upper, for replacement of upper instrument tray |
| 00850005757719 | lid for surgical tray, replacements |
| 00850005757702 | Cannulated Drill Bit 4.7mm X 180mm Quick Connect Cannulated for a 1.3mm K-Wire (Kirshner Wire) |
| 00850005757696 | Cannulated Drill Bit 4mm X 180mm Quick Connect Cannulated for a 1.3mm K-Wire (Kirshner Wire) |
| 00850005757689 | Depth Gauge 1.3mm Diameter K-Wire 80mm to 130mm increments |
| 00850005757672 | Screwdriver T25 Hex Cannulated |
| 00850005757665 | Tissue Protector Drill Guide 4.0mm and 5.0mm |
| 00850005757634 | CANNULATED TAPERED SCREW OVERALL LENGTH 130MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 30MM DIST |
| 00850005757627 | CANNULATED TAPERED SCREW OVERALL LENGTH 130MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 30MM DIST |
| 00850005757610 | CANNULATED TAPERED SCREW OVERALL LENGTH 120MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 35MM DIST |
| 00850005757603 | CANNULATED TAPERED SCREW OVERALL LENGTH 120MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 35MM DIST |
| 00850005757580 | CANNULATED TAPERED SCREW OVERALL LENGTH 110MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 30MM DIST |
| 00850005757573 | CANNULATED TAPERED SCREW OVERALL LENGTH 110MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 35MM DIST |
| 00850005757566 | CANNULATED TAPERED SCREW OVERALL LENGTH 110MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 25MM DIST |
| 00850005757559 | CANNULATED TAPERED SCREW OVERALL LENGTH 110MM PROXIMAL DIAMETER 5MM PROXIMAL LENGHT 30MM DIST |
| 00850005757535 | CANNULATED TAPERED SCREW OVERALL LENGTH 110MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 35MM DI |
| 00850005757511 | CANNULATED TAPERED SCREW OVERALL LENGTH 100MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 40MM DIST |
| 00850005757504 | CANNULATED TAPERED SCREW OVERALL LENGTH 100MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 40MM DIST |
| 00850005757498 | CANNULATED TAPERED SCREW OVERALL LENGTH 100MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 30MM DIST |
| 00850005757481 | CANNULATED TAPERED SCREW OVERALL LENGTH 100MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 30MM DIST |
| 00850005757474 | CANNULATED TAPERED SCREW OVERALL LENGTH 100MM PROXIMAL DIAMETER 5MM PROXIMAL LENGHT 40MM DIST |
| 00850005757443 | CANNULATED TAPERED SCREW OVERALL LENGTH 100MM PROXIMAL DIAMETER 5MM PROXIMAL LENGHT 30MM DIST |
| 00850005757436 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 40MM DISTA |
| 00850005757405 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 30MM DISTA |
| 00850005757382 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 25MM DISTA |
| 00850005757375 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 40MM DIS |
| 00850005757368 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 40MM DIS |
| 00850005757351 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 30MM DIS |
| 00850005757344 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 30MM DIS |
| 00850005757337 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 25MM DIS |
| 00850005757320 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 25MM DIS |
| 00850005757313 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 5MM PROXIMAL LENGHT 40MM DISTA |
| 00850005757290 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 5MM PROXIMAL LENGHT 30MM DISTA |
| 00850005757283 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 5MM PROXIMAL LENGHT 30MM DISTA |
| 00850005757276 | CANNULATED TAPERED SCREW OVERALL LENGTH 90MM PROXIMAL DIAMETER 5MM PROXIMAL LENGHT 25MM DISTA |
| 00850005757252 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 40MM DISTA |
| 00850005757245 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 40MM DISTA |
| 00850005757238 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 35MM DISTA |
| 00850005757221 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 35MM DISTA |
| 00850005757214 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 30MM DISTA |
| 00850005757207 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 6MM PROXIMAL LENGHT 30MM DISTA |
| 00850005757177 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 40MM DIS |
| 00850005757160 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 40MM DIS |
| 00850005757153 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 35MM DIS |
| 00850005757146 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 35MM DIS |
| 00850005757139 | CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 5.5MM PROXIMAL LENGHT 30MM DIS |
Trademark Results [RetroFix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RETROFIX 88357047 not registered Live/Pending |
RetroFix Screws, LLC 2019-03-26 |
 RETROFIX 78918924 not registered Dead/Abandoned |
Equipment Brokers, Inc. 2006-06-28 |
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