inforMED
PBFClass II

Orthopaedic Surgical Planning And Instrument Guides

Orthopedic · 21 CFR 888.3030

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

MDR events225All time
Recalls0All time
Registered firms70Currently listed
510(k) clearances27All time

Recent MDR events

225 adverse event reports on file

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Event type breakdown

Injury185
Malfunction39
Other1

Most-reported manufacturers

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Optimized Ortho Pty Ltd.87Corin Ltd62Optimized Ortho Pty Ltd52Corin Ltd.7Materialise Usa, Llc43d Systems3Blue Belt Technologies2Materialise Nv2

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

70 firms currently registered for this product code

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510(k) clearances

27 clearances for this product code

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