AFT ALLOGRAFT FILLER TUBE— 510(k) K060161

Name: FDA 510(k) clearance K060161
Creator: U.S. Food and Drug Administration
Published: 2006-03-21

Substantially Equivalent

Musculoskeletal Transplant Foundation

FDA 510(k) clearance K060161 for AFT ALLOGRAFT FILLER TUBE, Substantially Equivalent on 2006-03-21. Applicant: Musculoskeletal Transplant Foundation. Device class: 2.

Clearance details

Applicant: Musculoskeletal Transplant Foundation
Product code: Code MBP
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2006-01-20
Decision date: 2006-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K060161

K-number listed on FDA's recall record

Z-2004-2016 — Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.Class II·Terminated·Musculoskeletal Transplant Foundation, Inc.·20160421

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060161.

Data sourced from openFDA. This site is unofficial and independent of the FDA.