MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)— 510(k) K953915

Name: FDA 510(k) clearance K953915
Creator: U.S. Food and Drug Administration
Published: 1996-02-15

Substantially Equivalent for Some Indications

Depuy, Inc.

FDA 510(k) clearance K953915 for MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE), Substantially Equivalent for Some Indications on 1996-02-15. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1995-08-21
Decision date: 1996-02-15
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, 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 Depuy, Inc.

view all

K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS2005-03-14
K042664 — LPS UPPER EXTREMITY2004-12-08
K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY2004-07-22
K033959 — LPS2004-07-01
K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -0622004-05-28

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.