PUMA System— 510(k) K171703

Name: FDA 510(k) clearance K171703
Creator: U.S. Food and Drug Administration
Published: 2018-03-01

Substantially Equivalent

Panther Orthopedics, Inc.

FDA 510(k) clearance K171703 for PUMA System, Substantially Equivalent on 2018-03-01. Applicant: Panther Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Panther Orthopedics, Inc.
Product code: Product code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2017-06-08
Decision date: 2018-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTN

view all

K253115 — LARS ACJ2026-06-10
K252081 — SportLinc Syndesmosis Device2026-03-27
K253727 — Syndesmosis TightRope PRO2025-12-22
K251643 — Synchfix EVT2025-10-29
K251134 — RipCord2025-07-11

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.