ARTHROPLANE— 510(k) K932869

Name: FDA 510(k) clearance K932869
Creator: U.S. Food and Drug Administration
Published: 1994-03-25

Substantially Equivalent

Synvasive Technology, Inc.

FDA 510(k) clearance K932869 for ARTHROPLANE, Substantially Equivalent on 1994-03-25. Applicant: Synvasive Technology, Inc.. Device class: 2.

Clearance details

Applicant: Synvasive Technology, Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1993-06-14
Decision date: 1994-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cordova, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

view all

K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12

More clearances from Synvasive Technology, Inc.

view all

K093046 — ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES2011-03-22
K070108 — ELIBRA DYNAMIC KNEE BALANCER2007-04-04
K972508 — SURGICAL BURS AND SURGICAL DRILL BITS1997-08-26
K961522 — KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN1996-09-23
K950009 — POWERGRIP(TM) COMPRESSION FIXATION DEVICE1995-08-18

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.