The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Xia Spine System Sacral Block Assembly.
| Device ID | K001653 |
| 510k Number | K001653 |
| Device Name: | XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Mary-catherine Dillon |
| Correspondent | Mary-catherine Dillon HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-30 |
| Decision Date | 2000-08-18 |