Pro-fix™ Precision Fixation System
GUDID D765PFB80
1.5 mm x 8.0 mm self-tapping titanium alloy bone fixation screw
Osteogenics Biomedical Inc
Craniofacial bone screw, non-bioabsorbable, non-sterile| Primary Device ID | D765PFB80 |
| NIH Device Record Key | ba4b09e1-b362-480e-96b8-fbe44a37e5ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pro-fix™ Precision Fixation System |
| Version Model Number | PFB8 |
| Company DUNS | 123853058 |
| Company Name | Osteogenics Biomedical Inc |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Device Dimensions
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D765PFB80 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093719
FDA Product Code
| DZL | Screw, Fixation, Intraosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
[D765PFB80]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-29 |
| Device Publish Date | 2021-01-21 |
On-Brand Devices [Pro-fix™ Precision Fixation System]
| D765PFT550 | 1.5 mm x 5.0 mm self-drilling titanium alloy tenting screw |
| D765PFT50 | 1.5 mm x 5.0 mm self-drilling titanium alloy tenting screw |
| D765PFT450 | 1.5 mm x 4.0 mm self-drilling titanium alloy tenting screw |
| D765PFT40 | 1.5 mm x 4.0 mm self-drilling titanium alloy tenting screw |
| D765PFT350 | 1.5 mm x 3.0 mm self-drilling titanium alloy tenting screw |
| D765PFT30 | 1.5 mm x 3.0 mm self-drilling titanium alloy tenting screw |
| D765PFMF550 | 1.5 mm x 5.0 mm self-drilling titanium alloy membrane fixation screw |
| D765PFMF50 | 1.5 mm x 3.0 mm self-drilling titanium alloy membrane fixation screw |
| D765PFT850 | 1.5 mm x 8.0 mm self-drilling fully threaded titanium alloy tenting screw |
| D765PFT80 | 1.5 mm x 8.0 mm self-drilling fully threaded titanium alloy tenting screw |
| D765PFT1050 | 1.5 mm x 10.0 mm self-drilling fully threaded titanium alloy tenting screw |
| D765PFT100 | 1.5 mm x 10.0 mm self-drilling fully threaded titanium alloy tenting screw |
| D765PFB850 | 1.5 mm x 8.0 mm self-tapping titanium alloy bone fixation screw |
| D765PFB80 | 1.5 mm x 8.0 mm self-tapping titanium alloy bone fixation screw |
| D765PFB1450 | 1.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screw |
| D765PFB140 | 1.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screw |
| D765PFB1250 | 1.5 mm x 12.0 mm self-tapping titanium alloy bone fixation screw |
| D765PFB120 | 1.5 mm x 12.0 mm self-tapping titanium alloy bone fixation screw |
| D765PFB1050 | 1.5 mm x 10.0 mm self-tapping titanium alloy bone fixation screw |
| D765PFB100 | 1.5 mm x 10.0 mm self-tapping titanium alloy bone fixation screw |
| D765PFTK120 | Profix Tenting Kit |
| D765PFMK200 | Profix Membrane Fixation Kit |
| D765PFBK120 | Profix Bone Kit |
| D765PFT0 | Profix Tray |
Trademark Results [Pro-fix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRO-FIX 90882126 not registered Live/Pending |
Moen Incorporated 2021-08-13 |
 PRO-FIX 87793840 5741053 Live/Registered |
CobbleStone Investments LLC 2018-02-12 |
 PRO-FIX 85066854 4060965 Live/Registered |
Osteogenics Biomedical, Inc. 2010-06-18 |
 PRO-FIX 85066853 4060964 Live/Registered |
Osteogenics Biomedical, Inc. 2010-06-18 |
 PRO-FIX 78757937 3246440 Live/Registered |
Brampton Technology, LTD. 2005-11-21 |
 PRO-FIX 73222484 1157160 Live/Registered |
Kane Enterprises Inc. 1979-07-06 |
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