Cleared Traditional

K230486 - Cove Strip

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

K230486 · SeaSpine Orthopedics Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K230486

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.

MQV Device Classification - Class 2, Special Controls

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 399
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