The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Xia Spinal System C-c Adaptor.
Device ID | K992792 |
510k Number | K992792 |
Device Name: | XIA SPINAL SYSTEM C-C ADAPTOR |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Karen Ariemma |
Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
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 | 1999-08-19 |
Decision Date | 1999-11-16 |
Summary: | summary |