Cleared Traditional

K121320 - C7 ANTERIOR CERVICAL INTERVERTEBRAL FUS...

K121320 is an FDA 510(k) clearance for C7 ANTERIOR CERVICAL INTERVERTEBRAL FUS..., manufactured by Medyssey Co, Ltd.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K121320 · Medyssey Co, Ltd. · Orthopedic device
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Aug 2012
Decision
100d
Days
Class 2
Risk

K121320 is an FDA 510(k) clearance for the C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Medyssey Co, Ltd. (Skokie, US). The FDA issued a Cleared decision on August 10, 2012 after a review of 100 days - within the typical 510(k) review window.

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 Medyssey Co, Ltd. devices

FDA 510(k) Submission Details - K121320

510(k) Number K121320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2012
Decision Date August 10, 2012
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 246
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K121320.
VUSION CS PLUS
K122588 · Ortho Development Corp. · Jun 2013
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
K122366 · Spineart · Oct 2012
AVS AS PEEK SPACER
K120486 · Stryker Spine · Aug 2012
HONOUR SPACER SYSTEM
K120345 · Nexxt Spine, LLC · Jun 2012
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120840 · L & K Biomed Co., Ltd. · May 2012
RELIANCE CERVICAL IBF SYSTEM
K120396 · Reliance Medical Systems, LLC · May 2012