Cleared Traditional

K230486 - Cove Strip

K230486 is the FDA 510(k) clearance for Cove Strip by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K230486 · SeaSpine Orthopedics Corporation · Orthopedic device
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Aug 2023
Decision
179d
Days
Class 2
Risk

K230486 is an FDA 510(k) clearance for the Cove Strip. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Irvine, US). The FDA issued a Cleared decision on August 21, 2023 after a review of 179 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K230486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2023
Decision Date August 21, 2023
Days to Decision 179 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
57d slower than avg
Panel avg: 122d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 - MQV Filler, Bone Void, Calcium Compound

All 231
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K230486.
Cove Putty, OsteoCove Putty
K231030 · SeaSpine Orthopedics Corporation · Sep 2023
Montage Flowable Settable, Resorbable Bone Paste
K231270 · Orthocon, Inc. · Sep 2023
Montage-QS Settable, Resorbable Bone Putty
K231903 · Orthocon, Inc. · Aug 2023
Mineral Collagen Composite Bioactive Extra Moldable
K231942 · Collagen Matrix, Inc. · Aug 2023
Graftys Quickset
K231714 · Graftys · Jul 2023
Bonalive Orthopedics granules
K231528 · Bonalive Biomaterials, Ltd. · Jul 2023