The following data is part of a premarket notification filed by Amendia, Inc. with the FDA for Overwatch Spine System.
| Device ID | K161842 |
| 510k Number | K161842 |
| Device Name: | Overwatch Spine System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Amendia, Inc. 1755 West Oak Parkway Marietta, GA 30062 |
| Contact | Bruce Hooper |
| Correspondent | Chelsea Proffitt Amendia, Inc. 1755 West Oak Parkway Marietta, GA 30062 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2016-10-13 |
| Summary: | summary |