The following data is part of a premarket notification filed by Internal Fixation Systems, Inc. with the FDA for Ifs Bone Fixation Devices.
| Device ID | K071035 |
| 510k Number | K071035 |
| Device Name: | IFS BONE FIXATION DEVICES |
| Classification | Screw, Fixation, Bone |
| Applicant | INTERNAL FIXATION SYSTEMS, INC. 10100 N.W. 116TH WAY, STE. 18 Miami, FL 33178 |
| Contact | Steve Hernandez |
| Correspondent | Steve Hernandez INTERNAL FIXATION SYSTEMS, INC. 10100 N.W. 116TH WAY, STE. 18 Miami, FL 33178 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-12 |
| Decision Date | 2007-08-13 |
| Summary: | summary |