Cleared Traditional

K934336 - SPINALPLANE (FDA 510(k) Clearance)

Class I Orthopedic device.

K934336 · Synvasive Technology, Inc. · Orthopedic device
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Mar 1995
Decision
549d
Days
Class 1
Risk

K934336 is an FDA 510(k) clearance for the SPINALPLANE. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Synvasive Technology, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on March 10, 1995 after a review of 549 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 K934336 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 07, 1993
Decision Date March 10, 1995
Days to Decision 549 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
427d slower than avg
Panel avg: 122d · This submission: 549d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & 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.