Home / 510(k) Clearances / K972367

510(k) K972367

STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT by Stryker Instruments — Product Code KIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1997
Date Received
June 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
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 KIJ

  • K163308 — SMARTO (December 27, 2016)
  • K112599 — INSURGICAL SINGLE USE POWER EQUIPMENT (November 6, 2012)
  • K101563 — SMARTO (December 17, 2010)
  • K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115) (April 30, 1997)
  • K960711 — ACUMED BONE GRAFT SYSTEM (May 7, 1996)
  • K951450 — SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY (May 17, 1995)
  • K944488 — S & S ORTHOPEDIC WIRE DRIVER 701 (March 2, 1995)
  • K941285 — ARTHREX GRAFT HARVESTING KIT (November 14, 1994)
  • K933101 — THE OSTEOMED B POWER SYSTEM AND ACCESSORIES (November 7, 1994)
  • K933337 — R AND D BATTERY REPLACEMENT (April 5, 1994)