FDA Product Code MNU: Staple, Absorbable
Leading manufacturers include OSSIO , Ltd. and Arthrex, Inc..
4
Total
4
Cleared
82d
Avg days
2001
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
58d
recently vs 90d historically
FDA 510(k) Cleared Staple, Absorbable Devices (Product Code MNU)
4 devices
Cleared
Aug 28, 2024
OSSIOfiber® Compression Staple
OSSIO , Ltd.
Orthopedic
58d
Cleared
Nov 16, 2023
OSSIOfiber® Compression Staple
OSSIO , Ltd.
Orthopedic
48d
Cleared
Jan 21, 2022
OSSIOfiber® Staple
OSSIO , Ltd.
Orthopedic
158d
Cleared
Jun 19, 2001
ARTHREX BIO-TRANSFIX
Arthrex, Inc.
Orthopedic
63d
About Product Code MNU - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code MNU since 2001, with 4 receiving FDA clearance (average review time: 82 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - MNU Product Code
Recent submissions under MNU have taken an average of 58 days to reach a decision - down from 90 days historically, suggesting improved FDA processing for this classification.
MNU devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →