SYNFIX-LR SPACER

K072253OVD10/12/2007

Applicant

SYNTHES SPINE CO.LP

Intended Use

The Synthes SynFix™-LR is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix™-LR can be packed with autograft.

Indications for Use

DDD is defined as back pain of discogenic origin 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.

Predicate Devices

  • K062083 - Synthes SynFix™-LR (OVD)
  • P950002 - BAK Intervertebral Body Fusion Device (OVD)