COHORT(TM) ANTERIOR PLATE SYSTEM (APS)— 510(k) K950011

Name: FDA 510(k) clearance K950011
Creator: U.S. Food and Drug Administration
Published: 1995-11-06

Substantially Equivalent for Some Indications

Cohort Medical Products Group, Inc.

FDA 510(k) clearance K950011 for COHORT(TM) ANTERIOR PLATE SYSTEM (APS), Substantially Equivalent for Some Indications on 1995-11-06. Applicant: Cohort Medical Products Group, Inc.. Device class: 2.

Clearance details

Applicant: Cohort Medical Products Group, Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 1995-01-03
Decision date: 1995-11-06
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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K964975 — COHORT DISCECTOMY SYSTEMS (CDS)1997-02-24
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K943472 — COHORT AVB RETRACTOR SYSTEM1994-10-20
K943474 — CANNULATED BONE SCREW1994-10-14

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.