← FDA Medical Device Classifications

Fastener, Fixation, Nondegradable, Soft Tissue

MBI · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3040

Classification

FDA Product Code

MBI

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 888.3040

Review panel

OR

Medical specialty

Orthopedic

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

591

Registered establishments

269

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown