DeviceClearance

MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM— 510(k) K033476

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K033476 for MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 2004-01-20. Applicant: Howmedica Osteonics Corp.. Device class: 2.

Clearance details

Applicant
Howmedica Osteonics Corp.
Product code
Code KTT
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Allendale, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K033476

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033476.

Data sourced from openFDA. This site is unofficial and independent of the FDA.