Fassier-Duval Telescopic IM System— 510(k) K211292

Name: FDA 510(k) clearance K211292
Creator: U.S. Food and Drug Administration
Published: 2021-05-26

Substantially Equivalent

Pega Medical, Inc.

FDA 510(k) clearance K211292 for Fassier-Duval Telescopic IM System, Substantially Equivalent on 2021-05-26. Applicant: Pega Medical, Inc.. Device class: 2.

Clearance details

Applicant: Pega Medical, Inc.
Product code: Product code HSB
Device class: Class 2
Regulation: 21 CFR 888.3020
Advisory panel: Orthopedic
Date received: 2021-04-28
Decision date: 2021-05-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Laval, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSB

view all

K261189 — Freedom Nail Ankle Fusion System2026-10-19
K261345 — Pediatric Nailing Platform Femur2026-09-24
K261481 — Pangea Femur Reconstruction System2026-06-29
K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)2026-06-18
K261651 — Precice Max System and Precice Ankle Salvage System2026-06-18

More clearances from Pega Medical, Inc.

view all

K220190 — The GIRO Growth Modulation System2022-10-24
K192710 — The Simple Locking Intramedullary (Slim) System2020-06-24
K170704 — The Locking Pediatric Osteotomy Plate (LolliPOP) System2017-09-08
K163003 — Y3 Proximal Femoral Plate System2017-03-16
K160545 — GAP ENDO-EXO MEDULLARY SYSTEM2016-11-23

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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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