RetroFix CTM001055
GUDID 00850005757764
Surgical K-Wire Kirshner wire or pins Guide Wire 1.3mm Diameter 300 mm Length
RETROFIX SCREWS, LLC
Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire| Primary Device ID | 00850005757764 |
| NIH Device Record Key | aeb87c50-887f-4871-a047-0130b5908875 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RetroFix |
| Version Model Number | K-Wire, 1.3mm x 300mm PK 1 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005757764 [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 |
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
[00850005757764]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-31 |
| Device Publish Date | 2020-12-23 |
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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