Cleared Traditional

K201568 - Calvary Spine Pedicle Screw System

K201568 is the FDA 510(k) clearance for Calvary Spine Pedicle Screw System by Calvary Spine, LLC. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K201568 · Calvary Spine, LLC · Orthopedic device
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Nov 2020
Decision
154d
Days
Class 2
Risk

K201568 is an FDA 510(k) clearance for the Calvary Spine Pedicle Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Calvary Spine, LLC (Towson, US). The FDA issued a Cleared decision on November 12, 2020 after a review of 154 days - an extended review cycle.

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 Calvary Spine, LLC devices

Submission Details

510(k) Number K201568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2020
Decision Date November 12, 2020
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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

The OrthoMedix Group, Inc.
J.D. Webb

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 - NKB Thoracolumbosacral Pedicle Screw System

All 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K201568.
LineSider™ Spinal System
K203367 · Integrity Implants, Inc. · Dec 2020
CarboClear X Pedicle Screw System
K203317 · CarboFix Orthopedics , Ltd. · Nov 2020
Invictus™ Spinal Fixation System
K203056 · Alphatec Spine, Inc. · Nov 2020
Salvo® Spine System
K202476 · Spine Wave, Inc. · Nov 2020
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
K200790 · L & K Biomed Co., Ltd. · Oct 2020
ACURA Stabilization System
K200937 · Indius Medical Technologies Pvt. , Ltd. · Oct 2020