INFUSE BONE GRAFT

FDA premarket approval P050053/S012 · decided 2009-10-21

Approval details

PMA number

P050053

Supplement

S012

Supplement type

135 Review Track For 30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

INFUSE BONE GRAFT

Generic name

Bone grafting material, dental, with biologic component

Applicant

Medtronic, Inc.

Date received

2009-03-25

Decision date

2009-10-21

Days to decision

210 days

Decision code

APPR

Product code

NPZ

Advisory committee

Dental

Expedited review

No

Location

Memphis, TN

Statement

APPROVAL FOR A CHANGE TO THE KITTING AND STORAGE LOCATION FOR INFUSE® BONE GRAFT AND IS INDICATED FOR TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT, AN ALTERNATIVE TO AUTOGENOUS BONE GRAFT FOR SINUS AUGMENTATIONS, AND FOR LOCALIZED ALVEOLAR RIDGE AUGMENTATIONS FOR DEFECTS ASSOCIATED WITH EXTRACTION SOCKETS, AND FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE AT ONE LEVEL FRO

510(k) clearances by this applicant