Cleared Traditional

K070229 - RANGE SPINAL SYSTEM

K070229 is an FDA 510(k) clearance for RANGE SPINAL SYSTEM, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K070229 · K2m, Inc. · Orthopedic device
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May 2007
Decision
99d
Days
Class 2
Risk

K070229 is an FDA 510(k) clearance for the RANGE SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on May 3, 2007 after a review of 99 days - within the typical 510(k) review window.

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: 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 K2m, Inc. devices

FDA 510(k) Submission Details - K070229

510(k) Number K070229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2007
Decision Date May 03, 2007
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
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 269
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K070229.
SYNAPSE SYSTEM
K070573 · Synthes Spine Co.Lp · Jun 2007
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
K070295 · Trinity Orthopedics, LLC · May 2007
ROC LUMBAR SYSTEM
K063668 · Alphatec Spine, Inc. · May 2007
4S SPINAL SYSTEM
K063708 · Taeyeon Medical Co., Ltd. · Apr 2007
CAPSURE PEDICLE SCREW SYSTEM
K070245 · Spine Wave, Inc. · Apr 2007
SCIENT'X SPINAL SYSTEM
K062912 · Scient'X · Feb 2007