ACROMED PEDICLE SCREW— 510(k) K965102

Name: FDA 510(k) clearance K965102
Creator: U.S. Food and Drug Administration
Published: 1997-05-08

Substantially Equivalent

Acromed Corp.

FDA 510(k) clearance K965102 for ACROMED PEDICLE SCREW, Substantially Equivalent on 1997-05-08. Applicant: Acromed Corp.. Device class: 2.

Clearance details

Applicant: Acromed Corp.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1996-12-20
Decision date: 1997-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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K162189 — ANAX 5.5 Spinal System2016-08-30

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K981274 — ACROMED TIMX PLATE BASED LOW BACK SYSTEM1998-04-29
K980228 — UNIVERSITY PLATE ANTERIOR SYSTEM1998-04-14

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 →

Recalls naming K965102

K-number listed on FDA's recall record

Z-1011-2014 — M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.Class II·Terminated·Zimmer, Inc.·20131011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K965102.

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