The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Xia Spine System.
| Device ID | K984251 |
| 510k Number | K984251 |
| Device Name: | XIA SPINE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-27 |
| Decision Date | 1999-02-24 |
| Summary: | summary |