Home / 510(k) Clearances / K043334

510(k) K043334

BONE SOURCE HAC RAPID SETTING CEMENT by Stryker Instruments — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2005
Date Received
December 3, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

Other clearances by Stryker Instruments

  • K251971 — RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillati (September 25, 2025)
  • K250483 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (September 9, 2025)
  • K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBl (May 15, 2025)
  • K250327 — OptaBlate Radiofrequency (RF) Generator System (April 15, 2025)
  • K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (March 24, 2025)
  • K243958 — Consolidated Operating Room Equipment (CORE) 2 Console (March 21, 2025)
  • K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision (March 11, 2025)
  • K242834 — System 9 Sterile Battery Container (January 16, 2025)
  • K242266 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (October 21, 2024)
  • K241272 — Stryker Steri-Shield 8 Surgical Hoods and Togas (October 16, 2024)

Other clearances for product code GXP

  • K253732 — Permatage Flowable, Settable Bone Paste (March 13, 2026)
  • K253854 — MONTAGE XT Cranial Cement (January 2, 2026)
  • K241027 — Permatage Settable Bone Putty (September 26, 2024)
  • K232771 — Montage Flowable Settable, Resorbable Bone Paste (February 16, 2024)
  • K231475 — MONTAGE-QS Settable, Resorbable Bone Putty (October 12, 2023)
  • K221933 — MONTAGE Settable, Resorbable Bone Putty (January 13, 2023)
  • K182742 — DB-CMF (June 20, 2019)
  • K162864 — OsteoVation Impact (January 13, 2017)
  • K143661 — DirectInject (September 2, 2015)
  • K102018 — NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (September 23, 2010)