Cleared Traditional

K103081 - COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE

K103081 is an FDA 510(k) clearance for COVAORTHO-NERVE RESORBABLE COLLAGEN MEM..., manufactured by Biom'Up Sas. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 500-day FDA review.

K103081 · Biom'Up Sas · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
500d
Days
Class 2
Risk

K103081 is an FDA 510(k) clearance for the COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Biom'Up Sas (St-Priest, FR). The FDA issued a Cleared decision on March 2, 2012 after a review of 500 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5275 - the FDA neurology 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: 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 Neurology submissions.

View all Biom'Up Sas devices

FDA 510(k) Submission Details - K103081

510(k) Number K103081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2010
Decision Date March 02, 2012
Days to Decision 500 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
352d slower than avg
Panel avg: 148d · This submission: 500d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXI Device Classification - Class 2, Special Controls

Product Code JXI Cuff, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5275
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 Neurology devices follow this clearance model.

Regulatory Peers - JXI Cuff, Nerve

All 29
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K103081.
NEURAGEN 3D
K130557 · Integra LifeSciences Corporation · Apr 2014
FLEXIBLE COOAGEN NERVE CUFF
K131541 · Collagen Matrix, Inc. · Apr 2014
NERVE CUFF
K132660 · Cook Biotech Incorporated · Jan 2014
COLLAGEN NERVE WRAP
K060952 · Collagen Matrix, Inc. · Jul 2006
NEURA WRAP NERVE PROTECTOR
K041620 · Integra Lifesciences Corp. · Jul 2004
SURGISIS NERVE CUFF
K031069 · Cook Biotech, Inc. · May 2003