Cleared Traditional

K152200 - SurgTech Interbody System

K152200 is an FDA 510(k) clearance for SurgTech Interbody System, manufactured by Surgtech, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K152200 · Surgtech, Inc. · Orthopedic device
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Mar 2016
Decision
232d
Days
Class 2
Risk

K152200 is an FDA 510(k) clearance for the SurgTech Interbody System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Surgtech, Inc. (Westlake, US). The FDA issued a Cleared decision on March 25, 2016 after a review of 232 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 Surgtech, Inc. devices

FDA 510(k) Submission Details - K152200

510(k) Number K152200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2015
Decision Date March 25, 2016
Days to Decision 232 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
110d slower than avg
Panel avg: 122d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 Consultant

Backroads Consulting, Inc.
KAREN E. WARDEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 849
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K152200.
NuVasive CoRoent Thoracolumbar System
K153419 · Nu Vasive, Incorporated · Apr 2016
Opticage(R) Expandable Interbody Fusion Device
K160464 · Interventional Spine, Inc. · Apr 2016
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
K153495 · Ldr Spine USA · Mar 2016
NuVasive® Lumbar Interbody Implants
K153782 · Nu Vasive, Incorporated · Mar 2016
Cascadia Interbody System
K160547 · K2m · Mar 2016
NuVasive® TLX Interbody System
K153627 · Nu Vasive, Incorporated · Mar 2016