FDA Device Intelligence
Home › KOROS U.S.A., INC. › Koros-Scaglietti Osteotome Set

Koros-Scaglietti Osteotome Set

KOROS U.S.A., INC. · Model 7452-00 · UDI-DI 10840199543837

EMM Prescription
4
510(k) clearances
2
Adverse events
1
Recalls
132
Facilities

Description

Koros-Scaglietti Long Osteotome Straight 27.5cm 10-78" Set Consists of the Following: 1 x 7452-06, 1 x 7452-09, 1 x 7452-12, 1 x 7452-16 & 1 x 7452-19

Recalls

DateFirmReason
2008-04-16Biomet Microfixation, Inc.The working tips of the Stella Osteotomes are thicker than specification.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.