MNU — Staple, Absorbable Class II

FDA Device Classification

FDA product code MNU covers "Staple, Absorbable", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MNU
Device Class
Class II
Regulation Number
888.3030
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241932ossioOSSIOfiber® Compression StapleAugust 28, 2024
K233302ossioOSSIOfiber® Compression StapleNovember 16, 2023
K212594ossioOSSIOfiber® StapleJanuary 21, 2022
K011172arthrexARTHREX BIO-TRANSFIXJune 19, 2001