Cleared Traditional

K070293 - BENVENUE VCF OSTEO COIL SYSTEM

K070293 is an FDA 510(k) clearance for BENVENUE VCF OSTEO COIL SYSTEM, manufactured by Benvenue Medical, Inc.. The device is a Class 1 Orthopedic device with product code OCJ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K070293 · Benvenue Medical, Inc. · Orthopedic device
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Jul 2007
Decision
160d
Days
Class 1
Risk

K070293 is an FDA 510(k) clearance for the BENVENUE VCF OSTEO COIL SYSTEM. Classified as Spinal Channeling Instrument, Vertebroplasty (product code OCJ), Class I - General Controls.

Submitted by Benvenue Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 10, 2007 after a review of 160 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Benvenue Medical, Inc. devices

FDA 510(k) Submission Details - K070293

510(k) Number K070293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2007
Decision Date July 10, 2007
Days to Decision 160 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
38d slower than avg
Panel avg: 122d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

OCJ Device Classification - Class 1, General Controls

Product Code OCJ Spinal Channeling Instrument, Vertebroplasty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
Definition Create Channels In The Existing Spinal Bone Structure For The Flow Of Polymethylmethacrylate Bone Cement (pmma) Prior To A Vertebroplasty Procedure. Treatment Of Pathological Compression Fractures Of The Vertebral Body That May Result From Osteoporosis, Benign Lesions, And/or Malignant Lesions.
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.