Cleared Traditional

K202812 - IdentiTi Cervical Standalone Interbody ...

K202812 is the FDA 510(k) clearance for IdentiTi Cervical Standalone Interbody ... by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K202812 · Alphatec Spine, Inc. · Orthopedic device
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Dec 2020
Decision
85d
Days
Class 2
Risk

K202812 is an FDA 510(k) clearance for the IdentiTi Cervical Standalone Interbody System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsnad, US). The FDA issued a Cleared decision on December 18, 2020 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alphatec Spine, Inc. devices

Submission Details

510(k) Number K202812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2020
Decision Date December 18, 2020
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 114
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K202812.
SureMAX-SA Cervical Standalone System
K211111 · Additive Implants, Inc. · Jul 2021
ChoiceSpine Blackhawk Ti Cervical Spacer System
K203311 · Choice Spine, LLC · May 2021
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
K203129 · Precision Spine, Inc. · Jan 2021
Mecta-C Stand Alone Extension
K203076 · Medacta International S.A. · Nov 2020
DOLOMITE Anterior Cervical Stabilization System
K202065 · Astura Medical, LLC · Oct 2020
Hexanium® ACIF
K193000 · Spinevision, S.A.S. · Oct 2020