INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

FDA premarket approval P000058/S054 · decided 2013-12-06

Approval details

PMA number

P000058

Supplement

S054

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Generic name

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

Applicant

Medtronic Sofamor Danek USA, Inc.

Date received

2013-10-25

Decision date

2013-12-06

Days to decision

42 days

Decision code

APPR

Product code

NEK

Advisory committee

Orthopedic

Expedited review

No

Location

Memphis, TN

Statement

APPROVAL FOR EXTENSION OF THE RHBMP-2 DRUG SUBSTANCE EXPIRATION DATE FROM 60 TO 72 MONTHS USING THE APPROVED EXPIRATION DATE MODIFICATION PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICES AND IS INDICATED FOR THE FOLLOWING: SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED B

510(k) clearances by this applicant