Cleared Traditional

ChoiceSpine Tiger Shark Cervical Spacer System (K201643) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201643 · Choice Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
188d
Days
Class 2
Risk

K201643 is an FDA 510(k) clearance for the ChoiceSpine Tiger Shark Cervical Spacer System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Choice Spine, LLC (Knoxville, US). The FDA issued a Cleared decision on December 22, 2020 after a review of 188 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 Choice Spine, LLC devices

Submission Details

510(k) Number K201643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2020
Decision Date December 22, 2020
Days to Decision 188 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
66d slower than avg
Panel avg: 122d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K201643.
Ti3Z Cervical Interbody System
K202398 · Zavation Medical Products, LLC · Jan 2021
ZSFab Cervical Interbody System
K202488 · Zsfab, Inc. · Jan 2021
Tailored-C Cervical Interbody Fusion System
K200458 · Bespoke Technologies · Dec 2020
Lucero Medical Cervical Cage System
K200549 · Lucero Medical, LLC · Dec 2020
Atlas Spine Rebar (Ti) Spacer System
K202302 · Atlas Spine, Inc. · Oct 2020
CONSTRUX Mini PEEK Spacer System
K202949 · Orthofix, Inc. · Oct 2020