BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT— 510(k) K991398

Name: FDA 510(k) clearance K991398
Creator: U.S. Food and Drug Administration
Published: 1999-09-22

Substantially Equivalent

Stryker Leibinger

FDA 510(k) clearance K991398 for BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT, Substantially Equivalent on 1999-09-22. Applicant: Stryker Leibinger. Device class: 2.

Clearance details

Applicant: Stryker Leibinger
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 1999-04-22
Decision date: 1999-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXP

view all

K251959 — TnR Cranial Implant2026-07-30
K261265 — Permatage XT Settable Bone Putty2026-06-15
K253732 — Permatage Flowable, Settable Bone Paste2026-03-13
K253854 — MONTAGE XT Cranial Cement2026-01-02
K241027 — Permatage Settable Bone Putty2024-09-26

More clearances from Stryker Leibinger

view all

K052871 — STRYKER CUSTOM TI IMPLANT2005-12-16
K043250 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT2005-04-15
K041651 — STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM2004-09-30
K040022 — STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM2004-03-12
K022579 — STRYKER NAVIGATION SYSTEM-KNEE MODULE2003-06-02

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