DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM— 510(k) K974573

Name: FDA 510(k) clearance K974573
Creator: U.S. Food and Drug Administration
Published: 1998-02-18

Substantially Equivalent for Some Indications

Depuy, Inc.

FDA 510(k) clearance K974573 for DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM, Substantially Equivalent for Some Indications on 1998-02-18. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 1997-12-08
Decision date: 1998-02-18
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 KWP

view all

K143278 — LnK Posterior Cervical Fixation System2015-07-29
K150753 — OASYS System2015-06-09
K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System2015-06-04
K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

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 KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.