INFUSE(R) BONE GRAFT

FDA premarket approval P000058/S059 · decided 2015-12-04

Approval details

PMA number

P000058

Supplement

S059

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

2015-04-13

Decision date

2015-12-04

Days to decision

235 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 PERIMETER INTERBODY FUSION DEVICE OR THE CLYDESDALE SPINAL SYSTEM, UTILIZING SELECT OPEN SURGICAL PROCEDURES IN CONJUNCTION WITH SUPPLEMENTAL SPINAL FIXATION HARDWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE BONE GRAFT/ MEDTRONIC INTERBODY FUSION DEVICE AND IS INDICATED FOR:SPINAL FUSION PROCEDURES IN SKELETALLY MA

510(k) clearances by this applicant