CERAMIC TIPPED SKULL PIN— 510(k) K040363

Name: FDA 510(k) clearance K040363
Creator: U.S. Food and Drug Administration
Published: 2004-04-12

Substantially Equivalent

The Jerome Group, Inc.

FDA 510(k) clearance K040363 for CERAMIC TIPPED SKULL PIN, Substantially Equivalent on 2004-04-12. Applicant: The Jerome Group, Inc.. Device class: 2.

Clearance details

Applicant: The Jerome Group, Inc.
Product code: Code LYT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2004-02-13
Decision date: 2004-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moorestown, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K040363

K-number listed on FDA's recall record

Z-0998-2019 — Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1PK; 517CS/ Skull Pin 2-1/4in CT Sterl 4PK; 517DS/ Skull Pin 3in CT Sterl 4 PK; 522CS/ Skull Pin 2-1/4in CT Sterl 6PK; 522C/ SKULL PIN 2-1/4 CT 6 PKClass II·Terminated·Ossur Americas·20180621

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040363.

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