Cleared Traditional

K220296 - Manta Ray TDF Spacer

K220296 is the FDA 510(k) clearance for Manta Ray TDF Spacer by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K220296 · SeaSpine Orthopedics Corporation · Orthopedic device
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Feb 2023
Decision
366d
Days
Class 2
Risk

K220296 is an FDA 510(k) clearance for the Manta Ray TDF Spacer. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on February 3, 2023 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K220296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2022
Decision Date February 03, 2023
Days to Decision 366 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
244d slower than avg
Panel avg: 122d · This submission: 366d
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 218
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K220296.
Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer
K221490 · Stryker Spine · Feb 2023
Curiteva Porous PEEK Cervical Interbody Fusion System
K213030 · Curiteva, Inc. · Feb 2023
Eminent Spine 3D Cervical Interbody Fusion System
K212701 · Eminent Spine · Feb 2023
NuVasive Modulus-C Interbody System
K223731 · Nuvasive, Inc. · Jan 2023
Cervical Spine Truss System (CSTS) Interbody Fusion Device
K221266 · 4Web Medical, Inc. · Jan 2023
Kodiak C Spinal Implant System
K222806 · Met One Technologies, LLC · Dec 2022