The following data is part of a premarket notification filed by Imds (innovative Medical Device Systems) - Leis Me with the FDA for Axia Radial Head System.
| Device ID | K132735 |
| 510k Number | K132735 |
| Device Name: | AXIA RADIAL HEAD SYSTEM |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME 2710 DISCOVERY DRIVE, STE 600 CO-INNOVATION DIVISION Orlando, FL 32826 |
| Contact | Andrew Rynearson |
| Correspondent | Andrew Rynearson IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME 2710 DISCOVERY DRIVE, STE 600 CO-INNOVATION DIVISION Orlando, FL 32826 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2014-01-07 |
| Summary: | summary |