DeviceClearance

Product code HTN— Orthopedic

Arthrex FiberTape and TigerTape Cerclage Sutures

Classification name
Washer, Bolt Nut
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Total cleared
93
First cleared
Most recent

Market context for product code HTN

FDA has cleared 93 devices under product code HTN between 1984 and 2026, filed by 51 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HTN

Adverse events under product code HTN

product code HTN
Injury
310
Malfunction
639
Total
949

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 →

Recent clearances under product code HTN

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