VERSALOK SCREW ASSEMBLY (PROPOSED NAME)— 510(k) K961572

Name: FDA 510(k) clearance K961572
Creator: U.S. Food and Drug Administration
Published: 1996-09-17

Substantially Equivalent for Some Indications

Wrightmedicaltechnologyinc

FDA 510(k) clearance K961572 for VERSALOK SCREW ASSEMBLY (PROPOSED NAME), Substantially Equivalent for Some Indications on 1996-09-17. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1996-04-23
Decision date: 1996-09-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNH

view all

K162066 — Reliance Spinal Screw System2016-12-02
K162801 — CastleLoc Spinal Fixation System2016-11-03
K162143 — FixxSure® X-Link2016-09-23
K161151 — Spinal fixation system2016-09-21
K162189 — ANAX 5.5 Spinal System2016-08-30

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 MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.