IO Freedom
GUDID 00842078121818
3.5 x 32mm - Short Thread
EXTREMITY MEDICAL, LLC
Orthopaedic bone screw, non-bioabsorbable, non-sterile| Primary Device ID | 00842078121818 |
| NIH Device Record Key | 77642237-eca4-4380-9eed-b2be81bb7920 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IO Freedom |
| Version Model Number | 147-35232 |
| Company DUNS | 832720358 |
| Company Name | EXTREMITY MEDICAL, 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842078121818 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201556
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
[00842078121818]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2023-06-09 |
On-Brand Devices [IO Freedom]
| 00842078129708 | 6.5 x 110mm - Long Thread |
| 00842078129692 | 6.5 x 105mm - Long Thread |
| 00842078129685 | 6.5 x 100mm - Long Thread |
| 00842078121917 | 3.5 x 50mm - Short Thread |
| 00842078121887 | 3.5 x 45mm - Short Thread |
| 00842078121856 | 3.5 x 40mm - Short Thread |
| 00842078121849 | 3.5 x 38mm - Short Thread |
| 00842078121832 | 3.5 x 36mm - Short Thread |
| 00842078121825 | 3.5 x 34mm - Short Thread |
| 00842078121818 | 3.5 x 32mm - Short Thread |
| 00842078121801 | 3.5 x 30mm - Short Thread |
| 00842078121795 | 3.5 x 28mm - Short Thread |
| 00842078121788 | 3.5 x 26mm - Short Thread |
| 00842078121771 | 3.5 x 24mm - Short Thread |
| 00842078121764 | 3.5 x 22mm - Short Thread |
| 00842078121757 | 3.5 x 20mm - Short Thread |
| 00842078121740 | 3.5 x 50mm - Long Thread |
| 00842078121719 | 3.5 x 45mm - Long Thread |
| 00842078121689 | 3.5 x 40mm - Long Thread |
| 00842078121672 | 3.5 x 38mm - Long Thread |
| 00842078121665 | 3.5 x 36mm - Long Thread |
| 00842078121658 | 3.5 x 34mm - Long Thread |
| 00842078121641 | 3.5 x 32mm - Long Thread |
| 00842078121634 | 3.5 x 30mm - Long Thread |
| 00842078121566 | 6.5mm Screw Washer |
| 00842078121559 | 3.5mm Screw Washer |
| 00842078121429 | 6.5 x 95mm - Long Thread |
| 00842078121412 | 6.5 x 90mm - Long Thread |
| 00842078121405 | 6.5 x 85mm - Long Thread |
| 00842078121399 | 6.5 x 80mm - Long Thread |
| 00842078121382 | 6.5 x 75mm - Long Thread |
| 00842078121375 | 6.5 x 70mm - Long Thread |
| 00842078121368 | 6.5 x 65mm - Long Thread |
| 00842078121351 | 6.5 x 60mm - Long Thread |
| 00842078121344 | 6.5 x 55mm - Long Thread |
| 00842078121337 | 6.5 x 50mm - Long Thread |
| 00842078121320 | 6.5 x 45mm - Long Thread |
| 00842078121313 | 6.5 x 40mm - Long Thread |
| 00842078121306 | 6.5 x 45mm - Short Thread |
| 00842078121290 | 6.5 x 40mm - Short Thread |
| 00842078121221 | 4.5 x 60mm - Long Thread |
| 00842078121214 | 4.5 x 55mm - Long Thread |
| 00842078121207 | 4.5 x 50mm - Long Thread |
| 00842078121177 | 4.5 x 45mm - Long Thread |
| 00842078121146 | 4.5 x 40mm - Long Thread |
| 00842078121139 | 4.5 x 38mm - Long Thread |
| 00842078121122 | 4.5 x 36mm - Long Thread |
| 00842078121108 | 4.5 x 34mm - Long Thread |
| 00842078121092 | 4.5 x 32mm - Long Thread |
| 00842078121085 | 4.5 x 30mm - Long Thread |
Trademark Results [IO Freedom]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IO FREEDOM 90845461 not registered Live/Pending |
Extremity Medical, LLC 2021-07-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.