Cleared Traditional

K062986 - MEDTRONIC GRAFT DELIVERY SYRINGE

K062986 is the FDA 510(k) clearance for MEDTRONIC GRAFT DELIVERY SYRINGE by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K062986 · Medtronic Sofamor Danek USA, Inc. · General Hospital
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Dec 2006
Decision
70d
Days
Class 2
Risk

K062986 is an FDA 510(k) clearance for the MEDTRONIC GRAFT DELIVERY SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on December 8, 2006 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K062986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date December 08, 2006
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 293
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K062986.
CAPTION APPLICATOR
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K063613 · Terumo Medical Corp. · Dec 2006
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K062365 · Arthrex, Inc. · Sep 2006
MODIFICATION TO BONE GRAFT SYRINGE
K062173 · Wrightmedicaltechnologyinc · Aug 2006