BAK VISTA INTERBODY FUSION DEVICE

FDA Premarket Approval P950002 S011

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to add the bak vista interbody fusion device, which is manufactured from 65% peek optima and 35% toho besfight c6-uh carbon fiber, to the approved product line for the bak interbody fusion system. The device will be marketed under the trade name bak vista interbody fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (ddd) at the l2-s1 spinal levels. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level(s). Bak devices are to be implanted via an open anterior or posterior approach. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

DeviceBAK VISTA INTERBODY FUSION DEVICE
Generic NameIntervertebral Fusion Device With Bone Graft, Lumbar
ApplicantZimmer Spine, Inc
Date Received2002-08-29
Decision Date2003-07-08
PMAP950002
SupplementS011
Product CodeMAX 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Zimmer Spine, Inc 7375 Bush Lake Road minneapolis, MN 55439

Supplemental Filings

Supplement NumberDateSupplement Type
P950002Original Filing
S014 2004-01-21 Real-time Process
S013 2003-12-24 Real-time Process
S012 2003-09-29 Real-time Process
S011 2002-08-29 Normal 180 Day Track
S010
S009 2001-03-08 Special (immediate Track)
S008 1999-10-22 Real-time Process
S007 1999-02-11 Normal 180 Day Track
S006 1998-01-08 Normal 180 Day Track
S005 1997-12-15 Real-time Process
S004 1997-06-13 Real-time Process
S003 1997-03-19 Normal 180 Day Track
S002 1997-02-05 Real-time Process
S001 1996-12-26 Real-time Process

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