The following data is part of a premarket notification filed by Amendia, Inc. with the FDA for Savannah-t, Reduction, Savannah-t, High-top, Savannah-t, Monoaxial Mid-top, Savannah-t, Low-top, Savannah-link.
| Device ID | K132925 |
| 510k Number | K132925 |
| Device Name: | SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | AMENDIA, INC. 1755 W. OAK PARKWAY Marietta, GA 30062 |
| Contact | John Kapitan |
| Correspondent | John Kapitan AMENDIA, INC. 1755 W. OAK PARKWAY Marietta, GA 30062 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-18 |
| Decision Date | 2014-02-11 |
| Summary: | summary |