Cleared Traditional

K930573 - SYNVASIVE CERAMIC SUTTING BLOCK (FDA 510(k) Clearance)

Class I Orthopedic device.

K930573 · Synvasive Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
427d
Days
Class 1
Risk

K930573 is an FDA 510(k) clearance for the SYNVASIVE CERAMIC SUTTING BLOCK. Classified as Guide, Drill, Ligament (product code LXI), Class I - General Controls.

Submitted by Synvasive Technology, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on April 7, 1994 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Synvasive Technology, Inc. devices

Submission Details

510(k) Number K930573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1993
Decision Date April 07, 1994
Days to Decision 427 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
305d slower than avg
Panel avg: 122d · This submission: 427d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXI Guide, Drill, Ligament
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.