Cleared Traditional

K850255 - DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET (FDA 510(k) Clearance)

K850255 · Dow Corning Corp. Healthcare Industries Materials · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
99d
Days
-
Risk

K850255 is an FDA 510(k) clearance for the DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Hemlock, US). The FDA issued a Cleared decision on May 1, 1985 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel. 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 Dow Corning Corp. Healthcare Industries Materials devices

Submission Details

510(k) Number K850255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1985
Decision Date May 01, 1985
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -