The following data is part of a premarket notification filed by Ibalance Medical, Inc. with the FDA for Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant And Anchor, Akrfx Instrumentation.
| Device ID | K092381 |
| 510k Number | K092381 |
| Device Name: | IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION |
| Classification | Plate, Fixation, Bone |
| Applicant | IBALANCE MEDICAL, INC. 1835 MARKET ST., 29TH FL. Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan IBALANCE MEDICAL, INC. 1835 MARKET ST., 29TH FL. Philadelphia, PA 19103 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-10-27 |
| Summary: | summary |