GRAVITY Syndesmosis LP— 510(k) K170249

Name: FDA 510(k) clearance K170249
Creator: U.S. Food and Drug Administration
Published: 2017-06-30

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K170249 for GRAVITY Syndesmosis LP, Substantially Equivalent on 2017-06-30. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2017-01-27
Decision date: 2017-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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

More clearances from Wrightmedicaltechnologyinc

view all

K222835 — Prophecy Preoperative Navigation Alignment System2023-01-27
K213342 — PRO-DENSE LoVisc Bone Graft Substitute2022-01-05
K212996 — Sterile PHALINX Hammertoe System2021-11-16
K202815 — PROPHECY Preoperative Navigation Alignment System2021-03-10
K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System2021-01-08

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.