MNU · Class II · 21 CFR 888.3030

FDA Product Code MNU: Staple, Absorbable

Leading manufacturers include OSSIO , Ltd. and Arthrex, Inc..

4
Total
4
Cleared
82d
Avg days
2001
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Staple, Absorbable Devices (Product Code MNU)

4 devices
1–4 of 4
Cleared Aug 28, 2024
OSSIOfiber® Compression Staple
K241932
OSSIO , Ltd.
Orthopedic · 58d
Cleared Nov 16, 2023
OSSIOfiber® Compression Staple
K233302
OSSIO , Ltd.
Orthopedic · 48d
Cleared Jan 21, 2022
OSSIOfiber® Staple
K212594
OSSIO , Ltd.
Orthopedic · 158d
Cleared Jun 19, 2001
ARTHREX BIO-TRANSFIX
K011172
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 declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.