The following data is part of a premarket notification filed by Extremity Medical Llc with the FDA for Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw System.
| Device ID | K091577 |
| 510k Number | K091577 |
| Device Name: | EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany, NJ 07054 |
| Contact | Jamy Gannoe |
| Correspondent | Jamy Gannoe EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany, NJ 07054 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-02 |
| Decision Date | 2009-07-24 |
| Summary: | summary |