Cleared Traditional

K071857 - DELTA SPINAL FUSION SYSTEM

K071857 is an FDA 510(k) clearance for DELTA SPINAL FUSION SYSTEM, manufactured by Jemo Spine, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K071857 · Jemo Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
34d
Days
Class 2
Risk

K071857 is an FDA 510(k) clearance for the DELTA SPINAL FUSION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Jemo Spine, LLC (Murray, US). The FDA issued a Cleared decision on August 8, 2007 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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: 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 Jemo Spine, LLC devices

FDA 510(k) Submission Details - K071857

510(k) Number K071857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2007
Decision Date August 08, 2007
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 Orthopedic devices follow this clearance model.

Regulatory Peers - MNI Orthosis, Spinal Pedicle Fixation

All 206
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K071857.
PIONEER LOWTOP SPINAL ROD SYSTEM
K072187 · Pioneer Surgical Technology · Oct 2007
Optima ZS Transition Screw
K071880 · Zimmer Spine, Inc. · Oct 2007
PSS SYSTEM
K071438 · Spinal USA · Aug 2007
NUVASIVE OCT SYSTEM
K071435 · Nuvasive, Inc. · Aug 2007
SYNAPSE SYSTEM
K070573 · Synthes Spine Co.Lp · Jun 2007
ROC LUMBAR SYSTEM
K063668 · Alphatec Spine, Inc. · May 2007