Cleared Special

K183397 - ChoiceSpine Stealth Cervical Spacer System

K183397 is the FDA 510(k) clearance for ChoiceSpine Stealth Cervical Spacer System by Choicespine, LP. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 89-day FDA review.

K183397 · Choicespine, LP · Orthopedic device
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Mar 2019
Decision
89d
Days
Class 2
Risk

K183397 is an FDA 510(k) clearance for the ChoiceSpine Stealth Cervical Spacer System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Choicespine, LP (Knoxville, US). The FDA issued a Cleared decision on March 6, 2019 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Choicespine, LP devices

Submission Details

510(k) Number K183397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2018
Decision Date March 06, 2019
Days to Decision 89 days
Submission Type Special
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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 208
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K183397.
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K182608 · Silony Medical GmbH · Jun 2019
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nvc
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K183557 · Titan Spine, Inc. · Feb 2019