The following data is part of a premarket notification filed by Altiva Corp. with the FDA for Altes Buttress Plating System.
Device ID | K061482 |
510k Number | K061482 |
Device Name: | ALTES BUTTRESS PLATING SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | ALTIVA CORP. 9800 SOUTHERN PINES BLVD. SUITE I Charlotte, NC 28273 |
Contact | John Kapitan |
Correspondent | John Kapitan ALTIVA CORP. 9800 SOUTHERN PINES BLVD. SUITE I Charlotte, NC 28273 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-30 |
Decision Date | 2006-07-26 |
Summary: | summary |