AOC BONE WAX— 510(k) K041363

Substantially Equivalent

Ceremed , Inc.

FDA 510(k) clearance K041363 for AOC BONE WAX, Substantially Equivalent on 2004-07-27. Applicant: Ceremed , Inc.. Device class: Unclassified.

Clearance details

Applicant: Ceremed , Inc.
Product code: Code MTJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2004-05-21
Decision date: 2004-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MTJ

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Recalls naming K041363

K-number listed on FDA's recall record

Z-0658-2024 — Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 GClass II·Ongoing·Baxter Healthcare Corporation·20231206

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041363.

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