DeviceClearance

Product code HSB— Orthopedic

PRECICE Intramedullary Limb Lengthening System

Classification name
Rod, Fixation, Intramedullary And Accessories
Device class
Class 2
Regulation
21 CFR 888.3020
Advisory panel
Orthopedic
Total cleared
530
First cleared
Most recent

Market context for product code HSB

FDA has cleared 530 devices under product code HSB between 1977 and 2026, filed by 177 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 HSB

Adverse events under product code HSB

product code HSB
Death
49
Injury
12,083
Malfunction
6,561
Other
1
Total
18,694

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 HSB

1–100 of 530

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