Atlas FDA

AFT

FDA 510(k) clearance K042125 · decided 2005-07-28

Clearance details

K-number
K042125
Device name
AFT
Applicant
Musculoskeletal Transplant Foundation
Decision
Substantially Equivalent
Date received
2004-08-06
Decision date
2005-07-28
Days to decision
356 days
Clearance type
Traditional
Product code
MQV
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Edison, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void fil recall (Z-1066-2024)Musculoskeletal Transplant Foundation, Inc.2024-02-09
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void fil recall (Z-1067-2024)Musculoskeletal Transplant Foundation, Inc.2024-02-09
Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treat recall (Z-2004-2016)Musculoskeletal Transplant Foundation, Inc.2016-06-16