Cleared Traditional

K163366 - Shanghai Sanyou CARMEN Cervical Fusion ...

K163366 is an FDA 510(k) clearance for Shanghai Sanyou CARMEN Cervical Fusion ..., manufactured by Shanghai Sanyou Medical Co, Ltd.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K163366 · Shanghai Sanyou Medical Co, Ltd. · Orthopedic device
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Oct 2017
Decision
309d
Days
Class 2
Risk

K163366 is an FDA 510(k) clearance for the Shanghai Sanyou CARMEN Cervical Fusion System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Shanghai Sanyou Medical Co, Ltd. (Jiading District, CN). The FDA issued a Cleared decision on October 5, 2017 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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. Elevated predicate reliance profile. 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 Shanghai Sanyou Medical Co, Ltd. devices

FDA 510(k) Submission Details - K163366

510(k) Number K163366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2016
Decision Date October 05, 2017
Days to Decision 309 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
187d slower than avg
Panel avg: 122d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 471
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