inforMED
OSHClass IIImplant

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Orthopedic · 21 CFR 888.3070

Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.

MDR events106All time
Recalls1All time
Registered firms640Currently listed
510(k) clearances19All time

Recent MDR events

106 adverse event reports on file

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Event type breakdown

Injury64
Malfunction41
Other1

Most-reported manufacturers

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Medos International Sã rl Ch30Orthopediatrics, Inc20Orthopediatrics Corp.11Orthopediatrics, Corp7Stryker Spine-us6Astura Medical4Depuy Spine Inc4Nuvasive, Inc.4

Recalls

1 recall events for this product code

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Registered firms

640 firms currently registered for this product code

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510(k) clearances

19 clearances for this product code

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