Infuse (R) Bone Graft

FDA premarket approval P000058/S065 · decided 2017-09-21

Approval details

PMA number

P000058

Supplement

S065

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Infuse (R) Bone Graft

Generic name

Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction

Applicant

Medtronic Sofamor Danek USA, Inc.

Date received

2017-04-28

Decision date

2017-09-21

Days to decision

146 days

Decision code

APPR

Product code

NEK

Advisory committee

Orthopedic

Expedited review

No

Location

Memphis, TN

Statement

Approval for expansion of the approved indications for use of Infuse Bone Graft to include implantation with two additional interbody fusion devices, the Divergence-L Anterior/Oblique Lumbar Fusion System or the Pivox Oblique Lateral Spinal System, utilizing select open surgical procedures in conjunction with supplemental spinal fixation hardware, as well as modifying the surgical technique manual to allow surgeons to optionally wrap a resorbable suture around the fusion cage component to mainta

510(k) clearances by this applicant