MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS— 510(k) K885229

Name: FDA 510(k) clearance K885229
Creator: U.S. Food and Drug Administration
Published: 1989-09-29

Substantially Equivalent

Romano Surgical Instrumentation, Inc.

FDA 510(k) clearance K885229 for MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS, Substantially Equivalent on 1989-09-29. Applicant: Romano Surgical Instrumentation, Inc.. Device class: 1.

Clearance details

Applicant: Romano Surgical Instrumentation, Inc.
Product code: Code HSZ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1988-12-09
Decision date: 1989-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSZ

view all

K991588 — EMS SWISS ORTHOCLAST1999-07-21
K972860 — CURVTEK TSR SYSTEM1997-10-31
K970345 — ALIGNMENT INSTRUMENT1997-04-29
K955084 — ASPACH 65,000 (MODIFICATION)1996-01-17
K954080 — SODEM HIGH SPEED SYSTEM1995-10-16

More clearances from Romano Surgical Instrumentation, Inc.

view all

K880074 — RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS1988-03-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.