Cleared Traditional

K943804 - BONE SCREW

K943804 is an FDA 510(k) clearance for BONE SCREW, manufactured by Cohort Medical Products Group, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K943804 · Cohort Medical Products Group, Inc. · Orthopedic device
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Dec 1994
Decision
126d
Days
Class 2
Risk

K943804 is an FDA 510(k) clearance for the BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Cohort Medical Products Group, Inc. (Hayward, US). The FDA issued a Cleared decision on December 8, 1994 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Cohort Medical Products Group, Inc. devices

FDA 510(k) Submission Details - K943804

510(k) Number K943804 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 04, 1994
Decision Date December 08, 1994
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 810
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K943804.
BONE MULCH SCREW
K941941 · Biomet, Inc. · Feb 1995
DYONICS FIXATION SCREWS
K945182 · Smith & Nephew Dyonics, Inc. · Jan 1995
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213 · Howmedica Corp. · Dec 1994
CORTICAL BONE SCREW
K942340 · Acu Med, Inc. · Dec 1994
CANNULATED CANCELLOUS BONE SCREW
K942341 · Acu Med, Inc. · Dec 1994
PIONEER LABORATORIES CABLE SCREW
K941866 · Pioneer Surgical Technology · Nov 1994