OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY— 510(k) K130498

Clearance details

Applicant

Bacterin International, Inc.

Product code

Code MBP

Device class

Class 2

Regulation

21 CFR 888.3045

Advisory panel

Orthopedic

Date received

2013-02-26

Decision date

2013-05-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Belgrade, MT, US

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• Z-1526-2020 — OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis.Class II·Terminated·XTANT MEDICAL INC·20190503

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130498.