Cleared Traditional

K811201 - EFTEKHAR ACETABULAR STANDOFF (FDA 510(k) Clearance)

K811201 · Zimmer, Inc. · Orthopedic device
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May 1981
Decision
20d
Days
-
Risk

K811201 is an FDA 510(k) clearance for the EFTEKHAR ACETABULAR STANDOFF.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981 after a review of 20 days - a notably fast clearance cycle.

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: 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 Zimmer, Inc. devices

Submission Details

510(k) Number K811201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1981
Decision Date May 21, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -