TORQUEDRIVER WRENCH— 510(k) K870053

Name: FDA 510(k) clearance K870053
Creator: U.S. Food and Drug Administration
Published: 1987-03-11

Substantially Equivalent

Jerome Medical

FDA 510(k) clearance K870053 for TORQUEDRIVER WRENCH, Substantially Equivalent on 1987-03-11. Applicant: Jerome Medical. Device class: 1.

Clearance details

Applicant: Jerome Medical
Product code: Code HXC
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1987-01-07
Decision date: 1987-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt Laurel, NJ, US

Download summary PDF View on FDA.gov ↗

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K180092 — Intellitorq2018-03-08
K874358 — COMBINATION WRENCHES1987-11-23
K874359 — ADJUSTABLE WRENCHES1987-11-23
K813067 — SPINAL WRENCH1981-11-24
K791073 — WRENCH1979-06-20

More clearances from Jerome Medical

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K051918 — RESOLVE OPEN BACK HALO RINGS2005-08-17
K930021 — J TONGS1995-12-06
K930153 — SYSTEM III HALO RING1993-08-06
K882877 — JMS CERVICAL TRACTION DEVICE/HALO DEVICE1988-09-30
K864969 — JMS HALO APPLICATION TRAY1987-02-18

Adverse events under product code HXC

product code HXC

Malfunction: 851
Total: 851

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.