BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS

FDA premarket approval P960025 · decided 1999-02-02

Approval details

PMA number

P960025

Trade name

BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS

Generic name

Intervertebral fusion device with bone graft, lumbar

Applicant

Depuy Spine, Inc.

Date received

1996-07-25

Decision date

1999-02-02

Days to decision

922 days

Decision code

APRL

Product code

MAX

Advisory committee

Orthopedic

Expedited review

Yes

Location

Raynham, MA

Statement

Approval for the Lumbar I/F Cage(R) with VSP(R) Spine System. The device is indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360 degrees fusion) and posterior pedicle screw fixation. These pateints may have had a previous non-fusion spinal surgery at the involved spinal level(s). DDD is defined as dis

510(k) clearances by this applicant