The following data is part of a premarket notification filed by Impact Medical, Llc with the FDA for Orthopedic Fixation Systems.
| Device ID | K140216 |
| 510k Number | K140216 |
| Device Name: | ORTHOPEDIC FIXATION SYSTEMS |
| Classification | Plate, Fixation, Bone |
| Applicant | IMPACT MEDICAL, LLC 10110 SW NIMBUS AVE. STE B6 Portland, OR 97223 |
| Contact | Ej Duffy |
| Correspondent | Ej Duffy IMPACT MEDICAL, LLC 10110 SW NIMBUS AVE. STE B6 Portland, OR 97223 |
| Product Code | HRS |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-28 |
| Decision Date | 2014-05-01 |
| Summary: | summary |