IO FiX
GUDID 00842078106983
Lag Screw (Cannulated Polyaxial) 6.5 x 65
EXTREMITY MEDICAL, LLC
Orthopaedic bone screw, non-bioabsorbable, non-sterile| Primary Device ID | 00842078106983 |
| NIH Device Record Key | 71a3dc1b-12ff-4b61-b42e-8559b2e32ab5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IO FiX |
| Version Model Number | 118-65165 |
| 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 | 00842078106983 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121349
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842078106983]
Moist Heat or Steam Sterilization
[00842078106983]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-16 |
| Device Publish Date | 2019-07-08 |
On-Brand Devices [IO FiX]
| 00842078106006 | Lag Screw (solid polyaxial) - 5.0 x 25 mm |
| 00842078105733 | Lag Screw (cannulated tapered) - 5.0 x 40 mm |
| 00842078103913 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 38mm |
| 00842078103906 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 36mm |
| 00842078103883 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 34mm |
| 00842078103876 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 32mm |
| 00842078103869 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 30mm |
| 00842078103852 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 28mm |
| 00842078103845 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 26mm |
| 00842078103838 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 24mm |
| 00842078103821 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 22mm |
| 00842078103814 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 20mm |
| 00842078103777 | Lag Screw (Cannulated Tapered) 3.0 x 40mm |
| 00842078103760 | Lag Screw (Cannulated Tapered) 3.0 x 38mm |
| 00842078103753 | Lag Screw (Cannulated Tapered) 3.0 x 36mm |
| 00842078103739 | Lag Screw (Cannulated Tapered) 3.0 x 34mm |
| 00842078103722 | Lag Screw (Cannulated Tapered) 3.0 x 32mm |
| 00842078103715 | Lag Screw (Cannulated Tapered) 3.0 x 30mm |
| 00842078103708 | Lag Screw (Cannulated Tapered) 3.0 x 28mm |
| 00842078103692 | Lag Screw (Cannulated Tapered) 3.0 x 26mm |
| 00842078103685 | Lag Screw (Cannulated Tapered) 3.0 x 24mm |
| 00842078103678 | Lag Screw (Cannulated Tapered) 3.0 x 22mm |
| 00842078103661 | Lag Screw (Cannulated Tapered) 3.0 x 20mm |
| 00842078103579 | Lag Screw (Solid Polyaxial) 3.0 x 24 mm |
| 00842078103555 | Lag Screw (Solid Polyaxial) 3.0 x 20 mm |
| 00842078103531 | Lag Screw (Solid Polyaxial) 3.0 x 16 mm |
| 00842078103463 | Lag Screw (solid tapered) - 3.0 x 24 mm |
| 00842078103449 | Lag Screw (solid tapered) - 3.0 x 20 mm |
| 00842078103425 | Lag Screw (solid tapered) - 3.0 x 16 mm |
| 00842078103371 | IO Fix Trio Plate 10+ |
| 00842078103333 | IO Fix Trio Plate 6+ |
| 00842078105795 | Lag Screw (cannulated tapered) - 5.0 x 50 mm |
| 00842078105764 | Lag Screw (cannulated tapered) - 5.0 x 45 mm |
| 00842078105726 | Lag Screw (cannulated tapered) - 5.0 x 38 mm |
| 00842078105719 | Lag Screw (cannulated tapered) - 5.0 x 36 mm |
| 00842078105702 | Lag Screw (cannulated tapered) - 5.0 x 35 mm |
| 00842078105696 | Lag Screw (cannulated tapered) - 5.0 x 34 mm |
| 00842078105689 | Lag Screw (cannulated tapered) - 5.0 x 32 mm |
| 00842078105672 | Lag Screw (cannulated tapered) - 5.0 x 30 mm |
| 00842078105665 | Lag Screw (cannulated tapered) - 5.0 x 28 mm |
| 00842078105658 | Lag Screw (cannulated tapered) - 5.0 x 26 mm |
| 00842078105641 | Lag Screw (cannulated tapered) - 5.0 x 25 mm |
| 00842078105610 | Lag Screw (cannulated tapered) - 5.0 x 20 mm |
| 00842078105566 | X-Post (60 deg) 4.6 x 18 mm |
| 00842078105559 | X-Post (60 deg) 4.6 x 16 mm |
| 00842078105542 | X-Post (60 deg) 4.6 x 14 mm |
| 00842078105405 | Lag Screw (Cannulated Headed) 4.5 x 50 mm |
| 00842078105375 | Lag Screw (Cannulated Headed) 4.5 x 45 mm |
| 00842078105344 | Lag Screw (Cannulated Headed) 4.5 x 40 mm |
| 00842078105337 | Lag Screw (Cannulated Headed) 4.5 x 38 mm |
Trademark Results [IO FiX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IO FIX 85012995 4057095 Live/Registered |
Extremity Medical, LLC 2010-04-13 |
 IO FIX 85012870 not registered Dead/Abandoned |
Extremity Medical, LLC 2010-04-13 |
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