The following data is part of a premarket notification filed by Osteogenics Biomedical, Inc. with the FDA for Pro-fix Precision Fixation System Model Pfm#, Pfb#, Pft#.
| Device ID | K093719 |
| 510k Number | K093719 |
| Device Name: | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | OSTEOGENICS BIOMEDICAL, INC. 4620 71ST ST., BLDG. 78-79 Lubbock, TX 79424 |
| Contact | Dustyn Webb |
| Correspondent | Dustyn Webb OSTEOGENICS BIOMEDICAL, INC. 4620 71ST ST., BLDG. 78-79 Lubbock, TX 79424 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-02 |
| Decision Date | 2010-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D765PFT550 | K093719 | 000 |
| D765PFB80 | K093719 | 000 |
| D765PFB1450 | K093719 | 000 |
| D765PFB140 | K093719 | 000 |
| D765PFB1250 | K093719 | 000 |
| D765PFB120 | K093719 | 000 |
| D765PFB1050 | K093719 | 000 |
| D765PFB100 | K093719 | 000 |
| D765PFTK120 | K093719 | 000 |
| D765PFMK200 | K093719 | 000 |
| D765PFB850 | K093719 | 000 |
| D765PFT100 | K093719 | 000 |
| D765PFT1050 | K093719 | 000 |
| D765PFT50 | K093719 | 000 |
| D765PFT450 | K093719 | 000 |
| D765PFT40 | K093719 | 000 |
| D765PFT350 | K093719 | 000 |
| D765PFT30 | K093719 | 000 |
| D765PFMF550 | K093719 | 000 |
| D765PFMF50 | K093719 | 000 |
| D765PFT850 | K093719 | 000 |
| D765PFT80 | K093719 | 000 |
| D765PFBK120 | K093719 | 000 |