DeviceClearance

ARROW-LOK DIGITAL SYSTEM— 510(k) K112675

Substantially Equivalent

Arrowhead Medical Device Technologies, LLC

FDA 510(k) clearance K112675 for ARROW-LOK DIGITAL SYSTEM, Substantially Equivalent on 2011-12-12. Applicant: Arrowhead Medical Device Technologies, LLC. Device class: 2.

Clearance details

Applicant
Arrowhead Medical Device Technologies, LLC
Product code
Code HTY
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Collierville, TN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HTY

view all

More clearances from Arrowhead Medical Device Technologies, LLC

view all

Adverse events under product code HTY

product code HTY
Injury
544
Total
544

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 K112675

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 K112675.

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