Cleared Traditional

K962800 - STRYKER UNIVERSAL DRILL ATTACHMENTS & A...

K962800 is an FDA 510(k) clearance for STRYKER UNIVERSAL DRILL ATTACHMENTS & A..., manufactured by Stryker Instruments. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K962800 · Stryker Instruments · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
55d
Days
Class 1
Risk

K962800 is an FDA 510(k) clearance for the STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on September 11, 1996 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Instruments devices

FDA 510(k) Submission Details - K962800

510(k) Number K962800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1996
Decision Date September 11, 1996
Days to Decision 55 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 40
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K962800.
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544 · Synthes (Usa) · May 1997
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:
K970088 · Richard Wolf Medical Instruments Corp. · Apr 1997
SYNTHES STERILE DRILL BITS
K962913 · Synthes (Usa) · Nov 1996
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
K962215 · U.S. Medical Products, Inc. · Aug 1996
POWERCUT GOLD SURGICAL SYSTEM
K962022 · Baxter Healthcare Corp · Aug 1996
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
K961970 · Stryker Corp. · Jul 1996