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510(k) K962800

STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES by Stryker Instruments — Product Code HWE

K962800 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on September 11, 1996. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Stryker Instruments has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1996
Date Received
July 18, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Stryker Instruments

  • K261544 — Hydro Irrigation System (June 17, 2026)
  • K253679 — Hydro Irrigation System (May 8, 2026)
  • K252282 — SurgiCount+ System (March 16, 2026)
  • 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)

Other clearances for product code HWE

  • K143191 — IntelliSense Drill (February 20, 2015)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)
  • K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (May 26, 2005)
  • K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (January 5, 2005)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (September 18, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)

FDA data resources