|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
peek-optima alif spacer
|
BIOMET SPINE
|
K081636 |
08/07/2008
|
zyston arc interbody spacer
|
BIOMET SPINE (AKA EBI, LLC)
|
K110650 |
06/30/2011
|
zyston straight spacer system
|
BIOMET SPINE
|
K112014 |
10/17/2011
|
biomet lateral spacer system
|
BIOMET SPINE (AKA EBI, LLC)
|
K122989 |
10/24/2012
|
biomet fusion system
|
BIOMET SPINE
|
K141791 |
10/09/2014
|
biomet spine fusion system
|
BIOMET SPINE, LLC.
|
K142634 |
03/12/2015
|
biomet spine fusion system
|
Biomet Spine LLC.
|
K151483 |
07/31/2015
|
biomet spine fusion system
|
Biomet Spine LLC.
|
K153695 |
01/21/2016
|
biomet fusion system
|
Zimmer Biomet Spine Inc.
|
K163543 |
02/28/2017
|
zyston strut open titanium spacer system
|
Zimmer Biomet Spine Inc.
|
K171495 |
02/12/2018
|