Cleared Traditional

K092211 - CHESAPEAKE SPINAL SYSTEM

K092211 is the FDA 510(k) clearance for CHESAPEAKE SPINAL SYSTEM by K2m, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K092211 · K2m, Inc. · Orthopedic device
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Mar 2010
Decision
226d
Days
Class 2
Risk

K092211 is an FDA 510(k) clearance for the CHESAPEAKE SPINAL SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on March 5, 2010 after a review of 226 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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

Submission Details

510(k) Number K092211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2009
Decision Date March 05, 2010
Days to Decision 226 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
104d slower than avg
Panel avg: 122d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 148
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K092211.
INTERCONTINENTAL PLATE-SPACER
K103382 · Globus Medical, Inc. · May 2011
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
K102402 · Alphatec Spine, Inc. · Mar 2011
COROENT XLR STANDALONE SYSTEM
K100043 · Nuvasive, Inc. · Jun 2010
LIFE SPINE STAND-ALONE SPACER SYSTEM
K091301 · Life Spine · Dec 2009
INTREPID SPINAL SYSTEM
K091813 · Medtronic Sofamor Danek · Nov 2009
LUCENT MAGNUM
K083475 · Spinal Elements, Inc. · Feb 2009