DeviceClearance

MINI CANNULATED HEADED AND HEADLESS SCREW SET— 510(k) K120493

Substantially Equivalent

Instratek, Inc.

FDA 510(k) clearance K120493 for MINI CANNULATED HEADED AND HEADLESS SCREW SET, Substantially Equivalent on 2012-05-17. Applicant: Instratek, Inc.. Device class: 2.

Clearance details

Applicant
Instratek, Inc.
Product code
Code HWC
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Houston, TX, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HWC

view all

More clearances from Instratek, Inc.

view all

Adverse events under product code HWC

product code HWC
Death
20
Injury
15,910
Malfunction
8,192
Other
1
Total
24,123

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 K120493

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 K120493.

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