KRONNER SACRAL PIN GUIDE— 510(k) K895172

Name: FDA 510(k) clearance K895172
Creator: U.S. Food and Drug Administration
Published: 1989-09-12

Substantially Equivalent

Kronner Medical

FDA 510(k) clearance K895172 for KRONNER SACRAL PIN GUIDE, Substantially Equivalent on 1989-09-12. Applicant: Kronner Medical. Device class: 1.

Clearance details

Applicant: Kronner Medical
Product code: Code LXH
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1989-08-10
Decision date: 1989-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseburg, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LXH

view all

K192873 — SX-One MicroKnife2019-12-20
K140414 — IMBIBE NEEDLE2014-04-01
K101609 — SELF RETAINING SOFT TISSUE RETRACTOR2010-12-09
K001507 — MICROPERFORATION INSTRUMENT2000-06-14
K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM1996-01-22

More clearances from Kronner Medical

view all

K894228 — KRONNER SPHERICAL CUTTERS1990-07-23
K895171 — BLOOD GAS SAFETY SYRINGE1989-11-07
K895173 — SKELETAL FIXATION PIN1989-09-12
K871248 — KRONNER COLLES-FOREARM EXTERNAL FIXATION1987-06-03
K871247 — KRONNER UNIVERSAL FRAME EXTERNAL FIXATION1987-05-22

Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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.